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

Not Applicable

Terminated

• Conditions: Wound of Lower Leg (Physical Finding)
• Interventions: Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

• Registration Number: NCT03369756
• Lead Sponsor: B. Braun Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-12
• Study Start: 2018-02-20
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Results First Submitted: 2020-09-17
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Results First Posted: 2020-12-08
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prontosan Solution and Gel	Prontosan Wound Irrigation Solution and Prontosan Wound Gel	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (5)

Jupiter Medical Center; 🇺🇸 Jupiter, Florida, United States

Barry University Clinical Research; 🇺🇸 North Miami Beach, Florida, United States

Northwell Comprehensive Wound Care Healing Center and Hyperbarics; 🇺🇸 N. New Hyde Park, New York, United States

Harrisburg Foot and Ankle Center; 🇺🇸 Harrisburg, Pennsylvania, United States

St. Luke's Wound Care Center; 🇺🇸 Bethlehem, Pennsylvania, United States