Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Tegaderm Hydrogel	Tegaderm Hydrogel
A	Santyl	Santyl

Primary Outcome Measures

Name	Time	Method
Wound Appearance	28 days	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.

Secondary Outcome Measures