Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
This study has been completed.
Information provided by (Responsible Party):
First received: June 11, 2010
Last updated: April 11, 2013
Last verified: April 2013
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.
Diabetic Foot Ulcers
Drug: Tegaderm Hydrogel
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers
Primary Outcome Measures:
- Wound Appearance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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:
- Percent Change in Wound Area [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
Active Comparator: A
Apply one 24-hr period sufficient to cover the wound.
Active Comparator: B
Drug: Tegaderm Hydrogel
Apply once 24-hr period sufficient to cover the wound.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143727
|Richard C. Galperin, DPM
|Dallas, Texas, United States, 75224 |
||Herbert B Slade, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 11, 2010
|Results First Received:
||March 14, 2013
||April 11, 2013
||United States: Institutional Review Board
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Endocrine System Diseases