Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143727
• Other study ID #: 017-101-09-025
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2010
• Last updated: April 11, 2013
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Santyl
Apply one 24-hr period sufficient to cover the wound.
• Tegaderm Hydrogel
Apply once 24-hr period sufficient to cover the wound.

Locations

Country	Name	City	State
United States	Richard C. Galperin, DPM	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent Change in Wound Area		28 days	No