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This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.
Full description
The objectives of this study were to compare outcomes of diabetic foot ulcers (DFUs) treated with SANTYL or silver-containing products, both in combination with sharp debridement as needed. One hundred two subjects with qualifying DFUs were randomized to daily treatment with either SANTYL or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.
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Inclusion criteria
Exclusion criteria
Contraindications or hypersensitivity to the use of clostridial collagenase or products containing silver.
Participation in another clinical trial within thirty (30) days of Visit 1, or planned participation overlapping with this study.
Bleeding disorder that would preclude sharp debridement during the study.
Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
Infection with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, azotemia).
A target ulcer which involves the underlying tissues of tendon, muscle, or bone.
Diagnosis of chronic granulomatous disease, leukocyte adhesion defects, or severe neutropenia.
Current treatment (at the time of the Screening Visit) with any of the following:
Treatment of target ulcer with bioactive therapies within 1 month of screening:
Prior treatment of target ulcer for any length of time with clostridial collagenase ointment (SANTYL®).
Radiation therapy to the target lower extremity within 30 days prior to screening.
Medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Blood counts and blood chemistry values as follows:
Primary purpose
Allocation
Interventional model
Masking
102 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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