Status:
TERMINATED
Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)
Lead Sponsor:
B. Braun Medical Inc.
Conditions:
Wound of Lower Leg (Physical Finding)
Eligibility:
All Genders
18+ years
Phase:
NA
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 per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03369756
Start Date
February 20 2018
End Date
September 25 2019
Last Update
December 8 2020
Active Locations (5)
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1
Jupiter Medical Center
Jupiter, Florida, United States, 33458
2
Barry University Clinical Research
North Miami Beach, Florida, United States, 33169
3
Northwell Comprehensive Wound Care Healing Center and Hyperbarics
North New Hyde Park, New York, United States, 11042
4
St. Luke's Wound Care Center
Bethlehem, Pennsylvania, United States, 18015