Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)

• Sponsor: B. Braun Medical Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03369756
• Collaborator: (none)
• Enrollment: 43
• Locations: 5
• Arm: 1
• Actual Duration (Months): 19.1
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study evaluates the use of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of chronic leg wounds in adults. All participants will use Prontosan and report their personal observations regarding Quality of Life.

Condition or Disease	Intervention/Treatment	Phase
Wound of Lower Leg (Physical Finding)	Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study of Quality of Life in Patients With Chronic Leg Wound(s) Treated With Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel
• Actual Study Start Date: Feb 20, 2018
• Actual Primary Completion Date: Sep 25, 2019
• Actual Study Completion Date: Sep 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Prontosan Solution and Gel Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period	Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel; Wound cleansing using Prontosan solution and gel

Outcome Measures

Primary Outcome Measures

1. Wound-QoL Global Score [5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)]

   The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". These subscales cover items 1 to 16. Item 17 is not part of any of the subscales. The Wound-QoL can be used in clinical and observational studies and in daily practice. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). A "Total" or "Global" score is the average of at least 13 completed questions, regardless of which questions were not completed. The average of each of the 3 subscales can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.

Secondary Outcome Measures

1. Wound QoL Subscore; Body Dimension [5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)]

   The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Body" consists of Items #1 to #5. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.

2. Wound QoL Subscore; Psyche Dimension [5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)]

   The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Psyche" consists of Items #Items #6 to #10. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.

3. Wound QoL Subscore; Everyday Life Dimension [5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)]

   The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Everyday Life" consists of Items #Items #11 to #16. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. Generally, the higher values represents more of an impact to the patient for that item.

Other Outcome Measures

1. Wound Size [5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)]

   Change in wound size from Baseline/Week 1 to Final/Week 5. The change in the size of a wound will be evaluated using a disposable ruler to directly measure the overall wound dimensions at each scheduled visit to the study site (Weeks 1 and 5). These measurements will be done before any cleaning of the wound and after cleaning the wound (debridement).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female ≥18 years of age

2. Either 2 wounds on 1 leg or 1 wound on each leg or only 1 wound. Wound(s) must be located below the knee.

3. At least one wound must have a surface area ≥5 cm2 and ≤50 cm2 and it also must be present for ≥4 weeks

4. Mean global score ≥1.18 on the Wound-QoL questionnaire (this will be calculated by the electronic data capture [EDC] system at the time of screening to assess eligibility)

5. Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or walker)

Exclusion Criteria:

1. Prior treatment with Prontosan solution or Prontosan gel on the wound(s)

2. Infection in the wound(s)

3. Cartilage exposure in the wound(s)

4. Antibiotic therapy within 7 days prior to baseline (i.e., prior to first administration of study treatment). Topical antibiotics not applied to the wound are acceptable.

5. Current diagnosis of severe peripheral artery disease as indicated by clinical findings (i.e., no palpable pulse on both dorsal pedis and posterior tibial arteries of the affected limb) or an Ankle Brachial Index of < 0.5

6. Presence of gangrene in the wound(s) or on the leg(s)

7. Active (flare up) rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), psoriasis, sarcoidosis, or other skin disease. These subjects are allowed to receive oral, inhaled, or parenteral corticosteroids, immunosuppressive agents, or cytotoxic agents. Note: fibromyalgia is acceptable.

8. Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to the screening visit

9. Active radiation therapy below the hip

10. Subjects with medical conditions other then those identified in Exclusion Criteria 7 who are currently receiving or has received oral, or parenteral corticosteroids, immunosuppressive agents, or cytotoxic agents within 30 days prior to baseline (i.e., prior to first administration of study treatment) or is anticipated to require such agents during the course of the study

11. Clinical laboratory values that may impair wound healing; for example, hemoglobin <10 g/dL, or HbA1c ≥12%

12. Enrolled in any investigational drug or device study for any disease/indication within 30 days prior to the screening visit

13. Unable to comprehend or comply with study requirements, or inability to sign an informed consent form

14. Allergic to any of the components in Prontosan solution or Prontosan gel

15. Patients who, in the opinion of the Investigator, would not be suitable candidates for this study or have some impediment to their ability to heal

16. Preplanned surgery or procedures that would occur during the study (other than deemed minor and clinically non-significant by the Investigator) or that would interfere with the study

17. Phase 4 pressure ulcer as defined by full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible

18. Severe secondary lymphedema as diagnosed by clinical findings in inferior members (e.g., legs)

19. A diagnosis of malnutrition as determined by either a low BMI (<18.5 kg/m2), or on the combined finding of weight loss together with reduced BMI (age-specific)

20. Employee of the Investigator or study center, with direct involvement in the study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jupiter Medical Center	Jupiter	Florida	United States	33458
2	Barry University Clinical Research	North Miami Beach	Florida	United States	33169
3	Northwell Comprehensive Wound Care Healing Center and Hyperbarics	N. New Hyde Park	New York	United States	11042
4	St. Luke's Wound Care Center	Bethlehem	Pennsylvania	United States	18015
5	Harrisburg Foot and Ankle Center	Harrisburg	Pennsylvania	United States	17112

Sponsors and Collaborators

• B. Braun Medical Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 14, 2018
• Informed Consent Form - Sep 21, 2017
• Statistical Analysis Plan - Nov 4, 2019

More Information

Additional Information:

• Wound-QoL Short Manual, dated September 2015
• Measuring wounds on Wound Care Advisor

Publications

• Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
• Augustin M, Baade K, Herberger K, et al. Use of the Wound-QoL instrument in routine practice: feasibility, validity, and development of an implementation tool. Wound Medicine. 2014;5:4-8
• Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
• Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. Review.
• Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2:1-19. doi: 10.1111/j.1742-481X.2012.01097.x. Review.
• McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013 Oct;2(8):438-447. Review.
• Richmond NA, Maderal AD, Vivas AC. Evidence-based management of common chronic lower extremity ulcers. Dermatol Ther. 2013 May-Jun;26(3):187-96. doi: 10.1111/dth.12051. Review.
• Romanelli M, Dini V, Barbanera S, Bertone MS. Evaluation of the efficacy and tolerability of a solution containing propyl betaine and polihexanide for wound irrigation. Skin Pharmacol Physiol. 2010;23 Suppl:41-4. doi: 10.1159/000318266. Epub 2010 Sep 8.

• Responsible Party: B. Braun Medical Inc.
• ClinicalTrials.gov Identifier: NCT03369756
• Other Study ID Numbers: OPM-G-H-1506
• First Posted: Dec 12, 2017
• Last Update Posted: Dec 8, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Period Title: Overall Study
STARTED	43
COMPLETED	36
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (15.34)
Sex: Female, Male (Count of Participants)
Female	19 52.8%
Male	17 47.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 22.2%
Not Hispanic or Latino	28 77.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	15 41.7%
White	17 47.2%
More than one race	0 0%
Unknown or Not Reported	3 8.3%
Region of Enrollment (participants) [Number]
United States	36 100%

Outcome Measures

1. Primary Outcome

Title	Wound-QoL Global Score
Description	The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". These subscales cover items 1 to 16. Item 17 is not part of any of the subscales. The Wound-QoL can be used in clinical and observational studies and in daily practice. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). A "Total" or "Global" score is the average of at least 13 completed questions, regardless of which questions were not completed. The average of each of the 3 subscales can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Time Frame	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Outcome Measure Data

Analysis Population Description

All subjects who completed 4 weeks of treatment.

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Measure Participants	36
Week 1 / Baseline	2.41 (0.99)
Week 2	1.74 (1.15)
Week 3	1.51 (0.95)
Week 4	1.25 (0.90)
Week 5 / End	1.30 (0.87)

2. Secondary Outcome

Title	Wound QoL Subscore; Body Dimension
Description	The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Body" consists of Items #1 to #5. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Time Frame	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Outcome Measure Data

Analysis Population Description

All subjects who completed 4 weeks of treatment.

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Measure Participants	36
Body Subscore change, Baseline / Week 1 to Week 2	-0.76 (1.15)
Body Subscore change, Baseline / Week 1 to Week 3	-0.93 (1.28)
Body Subscore change, Baseline / Week 1 to Week 4	-1.19 (1.30)
Body Subscore change, Baseline / Week 1 to End / Week 5	-1.17 (1.21)

3. Secondary Outcome

Title	Wound QoL Subscore; Psyche Dimension
Description	The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Psyche" consists of Items #Items #6 to #10. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Time Frame	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Outcome Measure Data

Analysis Population Description

All subjects who completed 4 weeks of treatment.

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Measure Participants	36
Psyche Subscore change, Baseline / Week 1 to Week 2	-0.77 (1.12)
Psyche Subscore change, Baseline / Week 1 to Week 3	-1.04 (1.13)
Psyche Subscore change, Baseline / Week 1 to Week 4	-1.24 (1.27)
Psyche Subscore change, Baseline / Week 1 to End / Week 5	-1.26 (1.14)

4. Secondary Outcome

Title	Wound QoL Subscore; Everyday Life Dimension
Description	The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Everyday Life" consists of Items #Items #11 to #16. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. Generally, the higher values represents more of an impact to the patient for that item.
Time Frame	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Outcome Measure Data

Analysis Population Description

All subjects completing 4 weeks of treatment.

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Measure Participants	36
Everyday Life Subscore change, Baseline / Week 1 to Week 2	-0.58 (1.05)
Everyday Life Subscore change, Baseline / Week 1 to Week 3	-0.82 (1.04)
Everyday Life Subscore change, Baseline / Week 1 to Week 4	-1.11 (1.11)
Everyday Life Subscore change, Baseline / Week 1 to End / Week 5	-1.00 (0.99)

5. Other Pre-specified Outcome

Title	Wound Size
Description	Change in wound size from Baseline/Week 1 to Final/Week 5. The change in the size of a wound will be evaluated using a disposable ruler to directly measure the overall wound dimensions at each scheduled visit to the study site (Weeks 1 and 5). These measurements will be done before any cleaning of the wound and after cleaning the wound (debridement).
Time Frame	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Outcome Measure Data

Analysis Population Description

All subjects who completed 4 weeks of treatment.

Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
Measure Participants	36
Pre-Debridement Wound Size Change (Baseline/Week 1 to Week 5 / End)	-6.6 (18.3)
Post-Debridement Wound Size Change(Baseline/Week 1 to Final/Week 5)	-8.2 (19.2)

Adverse Events

Time Frame	Screening through 4th week of treatment (5 weeks total).
Adverse Event Reporting Description	All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
Arm/Group Title	Prontosan Solution and Gel
Arm/Group Description	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
All Cause Mortality
	Prontosan Solution and Gel
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Serious Adverse Events
	Prontosan Solution and Gel
	Affected / at Risk (%)	# Events
Total	5/43 (11.6%)
General disorders
Back Pain	1/43 (2.3%)	1
Infections and infestations
Cellulitis	1/43 (2.3%)	1
Injury, poisoning and procedural complications
Compression Fracture	1/43 (2.3%)	1
Contusion	1/43 (2.3%)	1
Fall	1/43 (2.3%)	1
Nervous system disorders
Neuralgia	1/43 (2.3%)	1
Other (Not Including Serious) Adverse Events
	Prontosan Solution and Gel
	Affected / at Risk (%)	# Events
Total	14/43 (32.6%)
General disorders
Burning Sensation	11/43 (25.6%)	62
Pain	3/43 (7%)	13
Paraesthesia	1/43 (2.3%)	1
Skin and subcutaneous tissue disorders
Burning Sensation	1/43 (2.3%)	1
Pain	1/43 (2.3%)	1
Pain of Skin	1/43 (2.3%)	10
Paraesthesia	4/43 (9.3%)	18
Pruritis	1/43 (2.3%)	4
Sensitive Skin	1/43 (2.3%)	1
Skin Disorder	1/43 (2.3%)	1

Limitations/Caveats

All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Institution acknowledges and shall cause Investigator to acknowledge that Sponsor has the right to use the Study Results in any manner deemed appropriate to Sponsor's business interests, both during, and following termination of, this Agreement. Where Institution and/or Investigator require the use of the Study Results for publication, the Institution and/or Investigator shall seek the Sponsor's written approval which shall not be unreasonably withheld.