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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound of Lower Leg (Physical Finding)

Intervention / Treatment
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* Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years of age Either 2 wounds on 1 leg or 1 wound on each leg or only 1 wound. Wound(s) must be located below the knee. At least one wound must have a surface area ≥5 cm2 and ≤50 cm2 and it also must be present for ≥4 weeks 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) Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or walker) Exclusion Criteria: Prior treatment with Prontosan solution or Prontosan gel on the wound(s) Infection in the wound(s) Cartilage exposure in the wound(s) 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. 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 Presence of gangrene in the wound(s) or on the leg(s) 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. Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to the screening visit Active radiation therapy below the hip 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 Clinical laboratory values that may impair wound healing; for example, hemoglobin <10 g/dL, or HbA1c ≥12% Enrolled in any investigational drug or device study for any disease/indication within 30 days prior to the screening visit Unable to comprehend or comply with study requirements, or inability to sign an informed consent form Allergic to any of the components in Prontosan solution or Prontosan gel 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 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 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 Severe secondary lymphedema as diagnosed by clinical findings in inferior members (e.g., legs) 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prontosan Solution and Gel<br>Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period | Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel<br>* Wound cleansing using Prontosan solution and gel<br>|

What is the study measuring?
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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) |