Diabetic Foot Ulcers Clinical Trial
Official title:
Evaluation of Windowed Casts With and Without Regranex® Gel for Healing
The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.
Management of diabetic leg or foot ulcers is based on certain principals: 1) effective
off-loading of pressure on the wound via specialized shoes, cast braces, or casts, 2)
removal of infected or necrotic tissue vial surgery or non-surgical methods, and 3)
optimization of wound healing by interventions that promote wound repair such as nutritional
support, provision of optimal moisture balance and growth factor therapy.
Application of casts or cast braces [below knee, removable boots with protective padding] to
protect and immobilize the ankle and foot have been demonstrated to provide superior wound
healing than less cumbersome types of shoe gear (1-3). The benefit of casting may be the
result of more effective off-loading of pressure than can be achieved with other devices,
but the inability of patients to remove their casts also appears to an important factor, as
non-compliance with removable cast-braces has been shown to be a pervasive and significant
issue (4,5). One critical concept in diabetic foot ulcer management is the relation between
chronically and limb loss — for each year a wound persists, a patient has a 25% risk for
major amputation due to complications from infection (6-8). Limb loss has a profound effect
on Diabetics' quality of life and rate of lower limb loss among diabetics is four per 1,000
person years in comparison with three per 10,000 person years (9-10).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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