Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
3140
Trial Sponsor
Clinical Trial Start Date
1998
0Primary Completion Date
2000
0Study Completion Date
2000
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Other0
Intervention Name
Dermagraft0
Comparator0
Interventional Trial Phase
Phase 30
Official Name
A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers0
Last Updated
May 21, 2018
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Study summary
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
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