Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT00512538|
Recruitment Status : Terminated (Interruption of business relations between Study Sponsor and Device Manufacturer)
First Posted : August 7, 2007
Last Update Posted : August 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot||Device: Bi-layered cell therapy (Apligraf)||Phase 3|
Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.
This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers|
|Study Start Date :||October 2000|
|Actual Study Completion Date :||September 2002|
- Time to complete wound healing (full epithelialization with no drainage) [ Time Frame: through 12 weeks ]
- Incidence of complete healing [ Time Frame: at 12 weeks ]
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): NCT00512538
|Principal Investigator:||Michael E Edmonds, MD||Diabetic Foot Clinic, Kings College Hospital, London UK|