Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Sponsor
Healthpoint (Industry)
Overall Status
Completed
CT.gov ID
NCT01656889
Collaborator
Smith & Nephew, Inc. (Industry)
447
50
2
28
8.9
0.3
Study Details
Study Description
Brief Summary
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
447 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Study Start Date
:
Aug 1, 2012
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HP802-247 HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. |
Biological: HP-802-247
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
|
| Placebo Comparator: Vehicle Vehicle Control (fibrinogen solution & thrombin solution without cells) |
Biological: Vehicle
(fibrinogen solution & thrombin solution without cells)
|
Outcome Measures
Primary Outcome Measures
- Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline [12 Weeks]
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
Secondary Outcome Measures
- Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline. [12 Weeks]
This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.
- Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline [Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first]
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
- Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure [Target ulcer status observed at two and three months following initial ulcer closure.]
Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
- Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks [Weekly, over the 12 week treatment period, baseline]
Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
- Change in Target Ulcer Pain [Weekly, over 12 week treament period, baseline]
Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
- Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline. [12 weeks]
This key secondary outcome was based on a Kaplan-Meier survival analysis.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Provide informed consent.
-
Age ≥ 18 years and of either sex.
-
Willing to comply with protocol instructions, including allowing all study assessments.
-
Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
-
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
-
Arterial supply adequacy confirmed
-
Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
-
Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
-
Acceptable state of health and nutrition
Exclusion Criteria:
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin
-
Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
-
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
-
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
-
Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
-
Refusal of or inability to tolerate compression therapy.
-
Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
-
History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
-
Any prior exposure to HP802-247 or its vehicle.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Glendale | Arizona | United States | 85306 | |
| 2 | Phoenix | Arizona | United States | 85006 | |
| 3 | Phoenix | Arizona | United States | 85012 | |
| 4 | Tucson | Arizona | United States | 85723 | |
| 5 | Tucson | Arizona | United States | 85724 | |
| 6 | Carlsbad | California | United States | 92009 | |
| 7 | Castro Valley | California | United States | 94546 | |
| 8 | Fresno | California | United States | 93720 | |
| 9 | Laguna Hills | California | United States | 92653 | |
| 10 | Long Beach | California | United States | 90822 | |
| 11 | Los Angeles | California | United States | 90095 | |
| 12 | San Diego | California | United States | 92013 | |
| 13 | San Francisco | California | United States | 94115 | |
| 14 | Stockton | California | United States | 95204 | |
| 15 | Sylmar | California | United States | 91342 | |
| 16 | Washington | District of Columbia | United States | 20007 | |
| 17 | Gainesville | Florida | United States | 32605 | |
| 18 | Hialeah | Florida | United States | 33013 | |
| 19 | Miami | Florida | United States | 33125 | |
| 20 | South Miami | Florida | United States | 33143 | |
| 21 | Tamarac | Florida | United States | 33321 | |
| 22 | Chicago | Illinois | United States | 60611 | |
| 23 | Chicago | Illinois | United States | 60612 | |
| 24 | Chicago | Illinois | United States | 60616 | |
| 25 | Jacksonville | Illinois | United States | 62650 | |
| 26 | North Chicago | Illinois | United States | 60064 | |
| 27 | Springfield | Illinois | United States | 62702 | |
| 28 | Baltimore | Maryland | United States | 21224 | |
| 29 | Boston | Massachusetts | United States | 02118 | |
| 30 | Cambridge | Massachusetts | United States | 02138 | |
| 31 | Las Vegas | Nevada | United States | 89119 | |
| 32 | Emerson | New Jersey | United States | 07630 | |
| 33 | New York | New York | United States | 10025 | |
| 34 | Chapel Hill | North Carolina | United States | 27599 | |
| 35 | Akron | Ohio | United States | 44307 | |
| 36 | Tulsa | Oklahoma | United States | 74127 | |
| 37 | Dunmore | Pennsylvania | United States | 18512 | |
| 38 | Wyomissing | Pennsylvania | United States | 19610 | |
| 39 | Dallas | Texas | United States | 75390 | |
| 40 | Fort Worth | Texas | United States | 76104 | |
| 41 | Fort Worth | Texas | United States | 76107 | |
| 42 | San Antonio | Texas | United States | 78229 | |
| 43 | St. George | Utah | United States | 84770 | |
| 44 | Roanoke | Virginia | United States | 24013 | |
| 45 | Tacoma | Washington | United States | 98431 | |
| 46 | Vancovuer | British Columbia | Canada | V5Z1M9 | |
| 47 | Hamilton | Ontario | Canada | L8R2R3 | |
| 48 | London | Ontario | Canada | N6C5J1 | |
| 49 | Sudbury | Ontario | Canada | P3E5J1 | |
| 50 | Sherbrooke | Quebec | Canada | J1H5N4 |
Sponsors and Collaborators
- Healthpoint
- Smith & Nephew, Inc.
Investigators
- Study Chair: Herbert B Slade, MD, Chief Medical Officer
- Study Director: Tommy Lee, MSHS, Associate Director Clinical Operations
- Principal Investigator: Robert Kirsner, MD, Investigator
- Principal Investigator: William Marston, MD, Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Healthpoint
ClinicalTrials.gov Identifier:
NCT01656889
Other Study ID Numbers:
- 802-247-09-029
First Posted:
Aug 3, 2012
Last Update Posted:
Mar 14, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Healthpoint
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were screened at 43 sites in the US and 5 in Canada; between August 22, 2012 and April 18, 2014; sites included independent and hospital wound clinics and private practice sites. |
|---|---|
| Pre-assignment Detail | Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. After completion of the treatment period, subjects entered a three-month follow up period. |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Period Title: Treatment Period, 12 Weeks | ||
| STARTED | 222 | 225 |
| COMPLETED | 210 | 214 |
| NOT COMPLETED | 12 | 11 |
| Period Title: Treatment Period, 12 Weeks | ||
| STARTED | 210 | 213 |
| COMPLETED | 206 | 204 |
| NOT COMPLETED | 4 | 9 |
Baseline Characteristics
| Arm/Group Title | HP802-247 | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle | Total of all reporting groups |
| Overall Participants | 211 | 210 | 421 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
136
64.5%
|
138
65.7%
|
274
65.1%
|
| >=65 years |
75
35.5%
|
72
34.3%
|
147
34.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.5
(14.8)
|
61.0
(12.5)
|
60.7
(13.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
71
33.6%
|
82
39%
|
153
36.3%
|
| Male |
140
66.4%
|
128
61%
|
268
63.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
36
17.1%
|
42
20%
|
78
18.5%
|
| Not Hispanic or Latino |
175
82.9%
|
168
80%
|
343
81.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
0.5%
|
0
0%
|
1
0.2%
|
| Asian |
3
1.4%
|
1
0.5%
|
4
1%
|
| Native Hawaiian or Other Pacific Islander |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Black or African American |
43
20.4%
|
34
16.2%
|
77
18.3%
|
| White |
160
75.8%
|
167
79.5%
|
327
77.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
1.4%
|
7
3.3%
|
10
2.4%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
9
4.3%
|
13
6.2%
|
22
5.2%
|
| United States |
202
95.7%
|
197
93.8%
|
399
94.8%
|
Outcome Measures
| Title | Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline |
|---|---|
| Description | For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed. |
| Time Frame | 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05 |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 211 | 210 |
| Wound Closed |
129
61.1%
|
126
60%
|
| Wound Not Closed |
82
38.9%
|
84
40%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5896 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | P-value is based on the chi-squared proportion of wounds closed in each group. | |
| Title | Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline. |
|---|---|
| Description | This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis. |
| Time Frame | 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 211 | 210 |
| Median (Full Range) [days] |
57.0
|
50.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .3675 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Title | Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline |
|---|---|
| Description | Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF. |
| Time Frame | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05 |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 211 | 210 |
| Baseline |
0
|
0
|
| Treatment Week 01 |
2.4
|
1.9
|
| Treatment Week 02 |
5.7
|
9.5
|
| Treatment Week 03 |
13.3
|
19.5
|
| Treatment Week 04 |
23.7
|
32.4
|
| Treatment Week 05 |
31.8
|
38.1
|
| Treatment Week 06 |
38.9
|
44.3
|
| Treatment Week 07 |
40.8
|
47.6
|
| Treatment Week 08 |
46.4
|
52.9
|
| Treatment Week 09 |
49.3
|
55.2
|
| Treatment Week 10 |
53.6
|
55.7
|
| Treatment Week 11 |
57.8
|
60.0
|
| Treatment Week 12 |
63.0
|
62.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 01 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6426 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 02 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .3843 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 03 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2792 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 04 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1502 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3823 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 06 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5528 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 07 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .02913 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 08 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3896 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 09 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3989 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8682 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 11 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8083 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Treatment Week 12 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6687 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure |
|---|---|
| Description | Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment. |
| Time Frame | Target ulcer status observed at two and three months following initial ulcer closure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure. Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle. Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 134 | 132 |
| Follow-up Visit 1 (2 months), Wounds Closed |
120
56.9%
|
114
54.3%
|
| Follow-up Visit 1 (2 months), Wounds Reopened |
14
6.6%
|
18
8.6%
|
| Follow-up Visit 2 (3 months), Wounds Closed |
118
55.9%
|
112
53.3%
|
| Follow-up Visit 2 (3 months), Wounds Reopened |
14
6.6%
|
16
7.6%
|
| Title | Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks |
|---|---|
| Description | Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. |
| Time Frame | Weekly, over the 12 week treatment period, baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score. |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 210 | 210 |
| Week 01 |
-3.74
(1.22)
|
-2.19
(1.22)
|
| Week 02 |
-4.18
(1.39)
|
-4.03
(1.38)
|
| Week 03 |
-6.14
(1.4)
|
-5.91
(1.39)
|
| Week 04 |
-8.2
(1.42)
|
-6.71
(1.41)
|
| Week 05 |
-10.6
(1.38)
|
-8.62
(1.37)
|
| Week 06 |
-11.04
(1.53)
|
-8.2
(1.52)
|
| Week 07 |
-11.57
(1.54)
|
-9.77
(1.53)
|
| Week 08 |
-11.18
(1.53)
|
-10.65
(1.53)
|
| Week 09 |
-12.7
(1.5)
|
-11.26
(1.49)
|
| Week 10 |
-12.55
(1.52)
|
-11.2
(1.51)
|
| Week 11 |
-12.35
(1.49)
|
-11.56
(1.48)
|
| Week 12 |
-12.1
(1.49)
|
-12.27
(1.48)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 01 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3601 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 02 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9398 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 03 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.905 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 04 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4471 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 06 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1815 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 07 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.399 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 08 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8027 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 09 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4913 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5227 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 11 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9366 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change in Target Ulcer Pain |
|---|---|
| Description | Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. |
| Time Frame | Weekly, over 12 week treament period, baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score. |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 210 | 210 |
| Week 01 |
-5.08
(1.08)
|
-5.05
(1.08)
|
| Week 02 |
-7.59
(1.25)
|
-6.95
(1.24)
|
| Week 03 |
-10.32
(1.27)
|
-9.58
(1.26)
|
| Week 04 |
-12.17
(1.3)
|
-10.26
(1.29)
|
| Week 05 |
-13.15
(1.23)
|
-13.17
(1.22)
|
| Week 06 |
-15.56
(1.35)
|
-13.03
(1.34)
|
| Week 07 |
-15.8
(1.38)
|
-14.51
(1.37)
|
| Week 08 |
-16.28
(1.38)
|
-14.81
(1.37)
|
| Week 09 |
-17.16
(1.32)
|
-15.97
(1.31)
|
| Week 10 |
-17.65
(1.32)
|
-15.91
(1.31)
|
| Week 11 |
-17.34
(1.33)
|
-16.47
(1.32)
|
| Week 12 |
-17.18
(1.36)
|
-16.39
(1.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 01 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9853 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 02 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7083 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 03 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6744 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2891 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9923 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 06 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1775 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 07 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.499 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 08 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4423 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 09 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5138 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3409 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 11 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6358 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | Week 12 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6753 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline. |
|---|---|
| Description | This key secondary outcome was based on a Kaplan-Meier survival analysis. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05. |
| Arm/Group Title | HP802-247 | Vehicle |
|---|---|---|
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| Measure Participants | 211 | 210 |
| Median (Full Range) [days to wound closure] |
57.0
|
50.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HP802-247, Vehicle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.05 |
| Comments | ||
| Method | Kaplan-Meier Survival analysis | |
| Comments | ||
Adverse Events
| Time Frame | Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-treatment period | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All subjects randomized to treatment were questioned about AE and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of AE. Some AE were only collected with respect to the organ system class. | |||
| Arm/Group Title | HP802-247 | Vehicle | ||
| Arm/Group Description | HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle | ||
All Cause Mortality |
||||
| HP802-247 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| HP802-247 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/222 (7.7%) | 21/225 (9.3%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 1/222 (0.5%) | 1 | 1/225 (0.4%) | 1 |
| Arteriosclerosis coronary artery | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Artrial fibrillation | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Cardiac arrest | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Hypertensive heart disease | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Myocardial infarction | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Colitis | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Gastrointestinal haemorrhage | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Rectal prolapse | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| General disorders | ||||
| Pain | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Infections and infestations | ||||
| Abscess limb | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Cellulitis | 2/222 (0.9%) | 2 | 4/225 (1.8%) | 4 |
| Diabetic gangrene | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Infected skin ulcer | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Osteomyelitis | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Pneumonia | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Sepsis | 0/222 (0%) | 0 | 2/225 (0.9%) | 2 |
| Septic shock | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Wound infection | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Gastrointestinal stoma complication | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Hip fracture | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Multiple injuries | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||
| Hypovolaemia | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Neuropathic arthropathy | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Pain in extremity | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Colon cancer | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Nervous system disorders | ||||
| Cerebral infarction | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Dysarthria | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Psychiatric disorders | ||||
| Completed suicide | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Depression suicidal | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal failure acute | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Dyspnoea | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Respiratory distress | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
| Respiratory failure | 1/222 (0.5%) | 1 | 1/225 (0.4%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 1/222 (0.5%) | 1 | 1/225 (0.4%) | 1 |
| Skin warm | 1/222 (0.5%) | 1 | 0/225 (0%) | 0 |
| Vascular disorders | ||||
| Deep-vein thrombosis | 0/222 (0%) | 0 | 1/225 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| HP802-247 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 119/222 (53.6%) | 107/225 (47.6%) | ||
| Gastrointestinal disorders | ||||
| Gastrointestinal Disorders | 7/222 (3.2%) | 9 | 8/225 (3.6%) | 8 |
| General disorders | ||||
| General disorders and administration site conditions | 14/222 (6.3%) | 15 | 11/225 (4.9%) | 14 |
| Infections and infestations | ||||
| Cellulitis | 8/222 (3.6%) | 8 | 10/225 (4.4%) | 15 |
| Wound infection | 6/222 (2.7%) | 6 | 7/225 (3.1%) | 8 |
| Infections and Infestations | 39/222 (17.6%) | 48 | 40/225 (17.8%) | 58 |
| Injury, poisoning and procedural complications | ||||
| Injury, poisoining and procedural complication | 27/222 (12.2%) | 31 | 22/225 (9.8%) | 24 |
| Wound complication | 9/222 (4.1%) | 9 | 13/225 (5.8%) | 14 |
| Metabolism and nutrition disorders | ||||
| Metabolism and Nutrition Disorders | 9/222 (4.1%) | 10 | 4/225 (1.8%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal and Connective Tissue Disorders | 19/222 (8.6%) | 23 | 18/225 (8%) | 23 |
| Pain in Extremity | 15/222 (6.8%) | 17 | 10/225 (4.4%) | 10 |
| Nervous system disorders | ||||
| Nervous System Disorders | 11/222 (5%) | 12 | 8/225 (3.6%) | 9 |
| Skin and subcutaneous tissue disorders | ||||
| Skin and Subcutaneous Tissue Disorders | 71/222 (32%) | 99 | 50/225 (22.2%) | 75 |
| Rash | 7/222 (3.2%) | 7 | 1/225 (0.4%) | 1 |
| Skin Ulcer | 42/222 (18.9%) | 53 | 31/225 (13.8%) | 44 |
| Venous Ulcer Pain | 7/222 (3.2%) | 9 | 4/225 (1.8%) | 5 |
| Vascular disorders | ||||
| Vascular Disorders | 11/222 (5%) | 13 | 8/225 (3.6%) | 10 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jaime E Dickerson, PhD |
|---|---|
| Organization | Smith & Nephew |
| Phone | 1-817-302-3914 |
| Jaime.Dickerson@smith-nephew.com |
Responsible Party:
Healthpoint
ClinicalTrials.gov Identifier:
NCT01656889
Other Study ID Numbers:
- 802-247-09-029
First Posted:
Aug 3, 2012
Last Update Posted:
Mar 14, 2016
Last Verified:
Feb 1, 2016