Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

NCT01143727 | Completed Phase 4 Results

• 1 other identifier: 017-101-09-025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent Change in Wound Area

  28 days

Study Arms (2)

A

ACTIVE COMPARATOR

Santyl

Drug: Santyl

B

ACTIVE COMPARATOR

Tegaderm Hydrogel

Drug: Tegaderm Hydrogel

Interventions

Santyl DRUG

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

A

Tegaderm Hydrogel DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

Richard C. Galperin, DPM

Dallas, Texas, 75224, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Jaime E. Dickerson, PhD; Sr. Director Clinical Affairs
• Organization: Healthpoint, Ltd.

jaime.dickerson@healthpoint.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-04

Locations

US (1)