Clinical Trial: The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers
Brief Summary: A prospective, single blinded randomized clinical study will be performed to determine if the injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or wound closure at a faster rate than conventional treatment.
Detailed Summary:
Diabetic lower extremity wounds and venous stasis wounds are two of the most challenging, costly medical problems of our population. Moreover, the Veterans Affairs population has a very high percentage of diabetes and venous stasis wounds.
Foot ulcers are the most common reason for a diabetic patient to be admitted to the hospital, and occur in approx 25% of patients (CDC) with an average stay of 3 weeks and a cost of 25,000$/ per treatment (21,22, 23). The pathophysiology of diabetic wound healing is characterized by microcirculatory ischemia and an abnormal wound healing cascade due to glycosylated cells and proteins.
Venous stasis disease affects 10-35% of the US population (24) and is characteristically difficult to treat, recurrent and costly. The dermal microcirculation is aberrant with cellular stasis, capillary leak, edema and prone to chronic wounds. As venous pressures increase in these patients, there is microcirculatory ischemia which predisposes to wound formation.
In the skin, the normal wound healing cellular cascade mechanism acts to restore epithelial components and ends in collagen deposition and scar formation. Imperative to this process is angiogenesis, cellular signaling, and cellular mitosis. These wound healing processes can be promoted by stem cell transplantation.
It is now known that lipoaspirate obtained by standard small volume liposunction techniques contains autologous mesenchymal stem cells. We propose that autologous stem cell transplantation via lipoaspirate injection to these recalcitrant wounds could be a safe and effective treatment modality. Because the cellular derangement of both diabetic wounds and venous stasis wounds is derived from abnormal cell signaling, micro-ischemia and abnorma
Sponsor: Washington D.C. Veterans Affairs Medical Center
Current Primary Outcome: wound measurements, healing of wounds, pictures of wounds [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Washington D.C. Veterans Affairs Medical Center
Dates:
Date Received: December 24, 2008
Date Started: February 2009
Date Completion: February 2010
Last Updated: December 24, 2008
Last Verified: December 2008
