Diabetic Foot Ulcers Clinical Trial
Official title:
A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).
Patients with diabetes are at risk for developing serious health problems that may affect
the feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the
lives of millions of diabetic patients, representing one of the most common and serious
complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer
(DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%.
More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5
will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb
amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as
a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more
than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States
each year occurs secondary to complications of diabetes mellitus. After a major amputation,
50% of patients will have another limb amputated within two years. Mortality rates
subsequent to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years.
Patients with a history of a DFU have a 40% greater mortality rate compared to patients with
diabetes alone. Improved treatments for DFUs are clearly a matter of great significance.
In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in
treating diabetic foot ulcers.
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