Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT01143727|
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: Santyl Drug: Tegaderm Hydrogel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2012|
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.
- Wound Appearance [ Time Frame: 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.
- Percent Change in Wound Area [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143727
|United States, Texas|
|Richard C. Galperin, DPM|
|Dallas, Texas, United States, 75224|
|Study Chair:||Herbert B Slade, MD||Healthpoint|