Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

NCT ID: NCT01143727

Last Updated: 2013-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-10-31

Brief Summary

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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A

Santyl

Group Type: ACTIVE_COMPARATOR

Santyl

Intervention Type: DRUG

Apply one 24-hr period sufficient to cover the wound.

B

Tegaderm Hydrogel

Group Type: ACTIVE_COMPARATOR

Tegaderm Hydrogel

Intervention Type: DRUG

Apply once 24-hr period sufficient to cover the wound.

Interventions

Santyl

Apply one 24-hr period sufficient to cover the wound.

Intervention Type: DRUG

Tegaderm Hydrogel

Apply once 24-hr period sufficient to cover the wound.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint

Locations

Richard C. Galperin, DPM

Dallas, Texas, United States

Countries

United States

Other Identifiers

017-101-09-025

Identifier Type: -

Identifier Source: org_study_id