Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Diabetic Foot
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 102
- Primary Endpoint
- Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
- •Eighteen (18) years of age or older, of either sex, and of any race or skin type.
- •Willing and able to make all required study visits.
- •Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
- •Willing to use an appropriate off-loading device to keep weight off of foot ulcers.
- •An ulcer present on any part of the plantar surface of the neuropathic foot or hallux which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit using the ARANZ Silhouette imaging device). The target ulcer duration must be ≥ 6 weeks but not more than 52 weeks (12 months) as documented in the subject's history or by subject report of onset, and which requires debridement.
- •Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.70 and ≤ 1.
- •If ABI \> 1.2, perfusion at or near the site of the ulcer should be confirmed; the foot is warm to the touch and has palpable pulses.
- •Separation of at least 5 cm (closest ulcer edge to other closest ulcer edge) if ≥ 2 ulcers are present as measured using the ARANZ Silhouette imaging device.
- •Diabetes mellitus (Type 1 or 2) requiring insulin or oral/injectable medications to control blood glucose levels.
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:
- •Systemic corticosteroids. If corticosteroid treatment was for ≥ 10 days, there must be a 1 week interval between discontinuation and screening.
- •Immunosuppressive agents
Outcomes
Primary Outcomes
Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.
Time Frame: 6 weeks
Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.
Secondary Outcomes
- Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events(6 weeks)