Safety Follow-Up to HP 802-247-09-015
Sponsor
Healthpoint (Industry)
Overall Status
Completed
CT.gov ID
NCT00900029
Collaborator
(none)
206
30
31
6.9
0.2
Study Details
Study Description
Brief Summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
Study Design
Study Type:
Observational
Actual Enrollment
:
206 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No HP802 Treatment Treatment received in Study 802-247-09-015 was HP802 |
Biological: No HP802 Treatment
|
| No HP802 Vehicle Treatment Treatment received in Study 802-247-09-015 was HP802 Vehicle |
Other: No HP802 Vehicle Treatment
|
Outcome Measures
Primary Outcome Measures
- The Number of Participants With Closed Target Ulcers at Each Visit [Over the 24-week study period, at each of the bi-monthly visits]
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
- Number of Subjects With Target Wound Closed for the First Time During the Study Period. [Over the 24-week study period, at each of the bi-monthly visits]
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
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
-
Willing to comply with protocol instructions, including allowing all study assessments.
-
Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
-
Subject has ended their participation in HP 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion.
Exclusion Criteria
- Subjects who refuse to provide written informed consent will be excluded from this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of AZ College of Medicine | Tucson | Arizona | United States | 85724 |
| 2 | Center for Clinical Research | Castro Valley | California | United States | 94546 |
| 3 | ILD Consulting, Inc. | Encinitas | California | United States | 92024 |
| 4 | Vascular Surgery Associates | Los Angeles | California | United States | 90048 |
| 5 | UCSD Wound Treatment and Research Center | San Diego | California | United States | 92013 |
| 6 | University of Miami | Miami | Florida | United States | 33186 |
| 7 | Doctors Research Network | South Miami | Florida | United States | 33143 |
| 8 | Robert J. Snyder | Tamarac | Florida | United States | 33321 |
| 9 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60154 |
| 10 | Passavant Area Hospital | Jacksonville | Illinois | United States | 62650 |
| 11 | Rosalind Franklin University | North Chicago | Illinois | United States | 60064 |
| 12 | Southern Illinois University | Springfield | Illinois | United States | 62702 |
| 13 | Johns Hopkins Wound Center | Baltimore | Maryland | United States | 21231 |
| 14 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 15 | New England Sinai Hospital | Stoughton | Massachusetts | United States | 02972 |
| 16 | Advanced Foot and Ankle Center | Las Vegas | Nevada | United States | 89119 |
| 17 | Vincent Giacalone | Emerson | New Jersey | United States | 07630 |
| 18 | St. Luke's Roosevelt Hospital Center | New York | New Jersey | United States | 10025 |
| 19 | Overglook Hospital Wound Healing Program | Summit | New Jersey | United States | 07901 |
| 20 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 21 | Harrisburg Foot and Ankle Center | Harrisburg | Pennsylvania | United States | 17112 |
| 22 | Center for Advanced Wound Care | Reading | Pennsylvania | United States | 19601 |
| 23 | Arlington Research Center | Arlington | Texas | United States | 76011 |
| 24 | Wound Care Consultants | Dallas | Texas | United States | 75093 |
| 25 | Southwest Regional Wound Care Center | Lubbock | Texas | United States | 79410 |
| 26 | Peripheral Vascular Associates | San Antonio | Texas | United States | 78205 |
| 27 | Dixie Regional Medical Center's Wound Clinic | Saint George | Utah | United States | 84770 |
| 28 | Lake Washington Vascular, PLLC | Bellevue | Washington | United States | 98004 |
| 29 | Providence Sacred Heart Medical Center Wound Clinic | Spokane | Washington | United States | 99204 |
| 30 | Aging Rehabilitation & Geriatric Care Research Center | London | Ontario | Canada | N6C5J1 |
Sponsors and Collaborators
- Healthpoint
Investigators
- Study Director: Hebert B Slade, MD, FAAAAI, Healthpoint
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00900029
Other Study ID Numbers:
- 802-247-09-016
First Posted:
May 12, 2009
Last Update Posted:
Aug 2, 2017
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Healthpoint
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011. |
|---|---|
| Pre-assignment Detail | Both PIs and subjects remained blinded to the therapy each subject received in 802-247-09-015. No test article was administered during this study and any therapy was at the discretion of the PI, with no restrictions. |
| Arm/Group Title | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Arm/Group Description | LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | Acellular vehicle applied weekly applied to wound surface every week |
| Period Title: Overall Study | |||||
| STARTED | 38 | 41 | 41 | 42 | 44 |
| COMPLETED | 35 | 37 | 38 | 35 | 38 |
| NOT COMPLETED | 3 | 4 | 3 | 7 | 6 |
Baseline Characteristics
| Arm/Group Title | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Acellular vehicle applied weekly | LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | Total of all reporting groups |
| Overall Participants | 44 | 38 | 41 | 41 | 42 | 206 |
| Age, Customized (participants) [Number] | ||||||
| 18-39 years |
1
2.3%
|
4
10.5%
|
3
7.3%
|
3
7.3%
|
4
9.5%
|
15
7.3%
|
| 40-49 years |
8
18.2%
|
6
15.8%
|
4
9.8%
|
6
14.6%
|
6
14.3%
|
30
14.6%
|
| 50-59 years |
11
25%
|
7
18.4%
|
10
24.4%
|
8
19.5%
|
6
14.3%
|
42
20.4%
|
| 60+ years |
24
54.5%
|
21
55.3%
|
24
58.5%
|
24
58.5%
|
26
61.9%
|
119
57.8%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
15
34.1%
|
17
44.7%
|
13
31.7%
|
19
46.3%
|
20
47.6%
|
84
40.8%
|
| Male |
29
65.9%
|
21
55.3%
|
28
68.3%
|
22
53.7%
|
22
52.4%
|
122
59.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
9
20.5%
|
11
28.9%
|
10
24.4%
|
6
14.6%
|
12
28.6%
|
48
23.3%
|
| Not Hispanic or Latino |
35
79.5%
|
27
71.1%
|
31
75.6%
|
35
85.4%
|
30
71.4%
|
158
76.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.5%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.4%
|
1
0.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
9
20.5%
|
8
21.1%
|
9
22%
|
11
26.8%
|
8
19%
|
45
21.8%
|
| White |
31
70.5%
|
29
76.3%
|
28
68.3%
|
29
70.7%
|
30
71.4%
|
147
71.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
6.8%
|
1
2.6%
|
4
9.8%
|
1
2.4%
|
3
7.1%
|
12
5.8%
|
Outcome Measures
| Title | The Number of Participants With Closed Target Ulcers at Each Visit |
|---|---|
| Description | At each visit the status of closed target ulcers was evaluated as remained closed or re-opened. |
| Time Frame | Over the 24-week study period, at each of the bi-monthly visits |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits. |
| Arm/Group Title | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Arm/Group Description | LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | Acellular vehicle applied weekly |
| Measure Participants | 27 | 21 | 25 | 23 | 18 |
| Enrollment |
27
61.4%
|
21
55.3%
|
25
61%
|
23
56.1%
|
18
42.9%
|
| Month 2 (Visit 1) |
22
50%
|
19
50%
|
24
58.5%
|
20
48.8%
|
17
40.5%
|
| Month 4 (Visit 2) |
25
56.8%
|
19
50%
|
22
53.7%
|
21
51.2%
|
16
38.1%
|
| Month 6 (Visit 3) |
25
56.8%
|
19
50%
|
21
51.2%
|
20
48.8%
|
15
35.7%
|
| Title | Number of Subjects With Target Wound Closed for the First Time During the Study Period. |
|---|---|
| Description | At each visit the status of open target ulcers was evaluated as "remained open" or "closed". |
| Time Frame | Over the 24-week study period, at each of the bi-monthly visits |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study. |
| Arm/Group Title | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Arm/Group Description | LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | Acellular vehicle applied weekly |
| Measure Participants | 8 | 16 | 13 | 12 | 20 |
| Month 2 (Visit 1) |
3
6.8%
|
1
2.6%
|
4
9.8%
|
2
4.9%
|
4
9.5%
|
| Month 4 (Visit 2) |
5
11.4%
|
3
7.9%
|
4
9.8%
|
5
12.2%
|
8
19%
|
| Month 6 (Visit 3) |
4
9.1%
|
4
10.5%
|
7
17.1%
|
6
14.6%
|
7
16.7%
|
Adverse Events
| Time Frame | The duration of the 24-week study period | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events. | |||||||||
| Arm/Group Title | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle | |||||
| Arm/Group Description | LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks | LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week | HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks | HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week | ||||||
All Cause Mortality |
||||||||||
| LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/38 (7.9%) | 0/41 (0%) | 4/41 (9.8%) | 5/42 (11.9%) | 4/44 (9.1%) | |||||
| Cardiac disorders | ||||||||||
| Acute coronary syndrome | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Arrhythmia | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 0/44 (0%) | 0 |
| Atrial fibrillation | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Cardiac failure congestive | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 2/42 (4.8%) | 2 | 0/44 (0%) | 0 |
| Cardiac valve disease | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Supraventricular tachycardia | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 2/44 (4.5%) | 2 |
| Infections and infestations | ||||||||||
| Cellulitis | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 0/44 (0%) | 0 |
| Pneumonia | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
| Wound infection | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||
| Femoral neck fracture | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
| Injury, poisoning and procedural complications | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 0/44 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||
| Type 2 diabetes mellitus | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Malignant soft tissue neoplasm | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 0/44 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Cerebrovascular accident | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Surgical and medical procedures | ||||||||||
| Alcohol detoxification | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 1/42 (2.4%) | 1 | 0/44 (0%) | 0 |
| Vascular disorders | ||||||||||
| Aneurysm ruptured | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
| Deep vein thrombosis | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 0/44 (0%) | 0 |
| Venous insufficiency | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||
| LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/38 (26.3%) | 6/41 (14.6%) | 5/41 (12.2%) | 11/42 (26.2%) | 14/44 (31.8%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 | 0/41 (0%) | 0 | 2/42 (4.8%) | 2 | 2/44 (4.5%) | 3 |
| Wound infection | 1/38 (2.6%) | 1 | 1/41 (2.4%) | 1 | 1/41 (2.4%) | 2 | 2/42 (4.8%) | 3 | 2/44 (4.5%) | 4 |
| Infections and infestations | 5/38 (13.2%) | 6 | 2/41 (4.9%) | 2 | 1/41 (2.4%) | 2 | 5/42 (11.9%) | 7 | 7/44 (15.9%) | 10 |
| Injury, poisoning and procedural complications | ||||||||||
| Injury, poisoning and procedural complications | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 | 2/41 (4.9%) | 3 | 0/42 (0%) | 0 | 1/44 (2.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Dry skin | 0/38 (0%) | 0 | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 | 0/42 (0%) | 0 | 2/44 (4.5%) | 2 |
| Skin ulcer | 4/38 (10.5%) | 5 | 2/41 (4.9%) | 2 | 0/41 (0%) | 0 | 3/42 (7.1%) | 4 | 6/44 (13.6%) | 9 |
| Skin and subcutaneous tissue disorders | 4/38 (10.5%) | 6 | 3/41 (7.3%) | 3 | 2/41 (4.9%) | 4 | 4/42 (9.5%) | 5 | 9/44 (20.5%) | 14 |
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, Inc. |
| Phone | 1-817-302-3914 |
| Jaime.Dickerson@smith-nephew.com |
Responsible Party:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00900029
Other Study ID Numbers:
- 802-247-09-016
First Posted:
May 12, 2009
Last Update Posted:
Aug 2, 2017
Last Verified:
Sep 1, 2016