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

Stopped early · Not applicable

Conditions studied: Wound of Lower Leg (Physical Finding)

In brief

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.

Key facts

Study ID

NCT03369756

Run by

B. Braun Medical Inc.

People needed

43

Starts

2018-02-20

Expected to finish

2019-09-25

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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 — North New Hyde Park, New York, United States
• St. Luke's Wound Care Center — Bethlehem, Pennsylvania, United States
• Harrisburg Foot and Ankle Center — Harrisburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.