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

A Prospective Study of Quality of Life in Patients With Chronic Leg Wound(s) Treated With Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel

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.

Study Overview

• Status: Terminated
• Conditions: Wound of Lower Leg (Physical Finding)
• Intervention / Treatment: Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center
    • North Miami Beach, Florida, United States, 33169
      • Barry University Clinical Research
  • New York
    • N. New Hyde Park, New York, United States, 11042
      • Northwell Comprehensive Wound Care Healing Center and Hyperbarics
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Wound Care Center
    • Harrisburg, Pennsylvania, United States, 17112
      • Harrisburg Foot and Ankle Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound-QoL Global Score	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.	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound QoL Subscore; Body Dimension	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.	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
Wound QoL Subscore; Psyche Dimension	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.	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
Wound QoL Subscore; Everyday Life Dimension	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.	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Size	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).	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Collaborators and Investigators

• Sponsor: B. Braun Medical Inc.

Publications and helpful links

General Publications

• 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.
• Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
• McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013 Oct;2(8):438-447. doi: 10.1089/wound.2012.0370.
• 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(Suppl 2):1-19. doi: 10.1111/j.1742-481X.2012.01097.x.
• 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.
• Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
• 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.
• 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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2018
• Primary Completion (ACTUAL): September 25, 2019
• Study Completion (ACTUAL): September 25, 2019

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: OPM-G-H-1506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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