Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.

Official Title
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Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Drug: Santyl
* Drug: Tegaderm Hydrogel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting the screening visit. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. Of either sex, aged 18 years or older. A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood glucose levels. A qualifying ulcer, defined as follows: Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1) Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to Section 9.4.2) Has not been treated or has not responded to treatment during the past 30 days Has an apparent area ≥ 3.0 cm² Requires debridement of the wound bed Is sufficiently moist to allow collection of wound fluid using a filter paper disc Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then toe pressure of >50 mmHg. Subject must be willing to use the Darco shoe off-loading device and insole, or a comparable device, as indicated. Subject able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol. Exclusion Criteria: Contraindications or known hypersensitivity to the test articles or their components. Cellulitis extending >2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone. Target ulcer tunneling per probing and visual assessment. Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol within 10 days of SCR visit. Concomitant illness or condition which, in the opinion of the Principal - Investigator, places the subject at risk for this study. The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Santyl | Drug: Santyl<br>* Apply one 24-hr period sufficient to cover the wound.<br>|
| Active Comparator: B<br>Tegaderm Hydrogel | Drug: Tegaderm Hydrogel<br>* Apply once 24-hr period sufficient to cover the wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Appearance | Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Wound Area |  | 28 days |