A Prospective Study of Quality of Life in Patients with Chronic Leg Wound(s) Treated with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel
Synopsis: B. Braun Medical Inc. (the Sponsor) has begun a research study of their products called Prontosan® Wound Irrigation Solution (Prontosan solution) and Prontosan® Wound Gel (Prontosan gel) as treatments for chronic leg wounds. These products have been approved by the United States (US) Food and Drug Administration (FDA) for cleaning and moistening chronic wounds. In this study, researchers would like to learn how a patient’s quality of life (QoL) changes while using these products to clean and moisten chronic leg wound(s). You are being asked to take part in this study because you have one or 2 chronic leg wound(s). If you do not want to take part in the study, this decision will be respected.
The main purpose of this study is to learn how/if a patient’s quality of life changes while using Prontosan solution and Prontosan gel to clean and moisten his/her chronic leg wound(s). Also, changes in wound size and wound appearance will be examined.
- 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 ≥10 cm2 and ≤16 cm2 and it also must be present for ≥12 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)
- 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 14 days prior to baseline (i.e., prior to first administration of study treatment)
- Previous diagnosis of peripheral artery disease, an Ankle Brachial Index of ≤ 0.7, and/or patient has no palpable pulse on both dorsal pedis and posterior tibial arteries of the affected limb
- Presence of gangrene in the wound(s) or on the leg(s)
- Active rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), psoriasis, sarcoidosis, or other skin disease. 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
- Currently receiving or has received oral, inhaled, 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, plasma total protein <4 g/dL, 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
- 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