Status:
WITHDRAWN
The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Conditions:
Diabetic Wounds
Venous Stasis Wounds
Eligibility:
All Genders
20-80 years
Phase:
NA
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...
Detailed Description
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 percentag...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with diabetic lower extremity wounds or venous stasis wounds present for more than 6 months whose wounds have failed to heal with conventional medical therapy will be included.
- Only fully consentable and compliant patients who are already scheduled to undergo surgical wound treatment or wound debridement in the operating room or in clinic will be included.
- Only patients with palpable distal pulses will be included.
- EXCLUSION CRITERIA:
- Patients with the following criteria will be excluded:
- HIV + patients
- patients on anticoagulants which cannot be stopped or corrected
- patients with cellulitis, infection, osteomyelitis, stage III or IV ulcers, \*those patients with no safe donor site availability and dialysis dependent end stage renal disease.
- Following normal operating room protocol, anticoagulants and aspirin will be stopped prior to the procedure.
- Patients will be randomly chosen to enter the intervention arm or the control arm of the study. Even social security numbers will be chosen to undergo the treatment arm and odd social security numbers will be chosen to undergo the control arm. After randomization, the control groups and the intervention groups will be analyzed to ensure that there are no statistically significant differences in patient profiles including: albumin levels, hematocrit, smoking status, and Hgb A1C values.
- Both insulin dependent and non-insulin dependent diabetic patients will be included and Hgb A1C values will be used to ensure both groups are similar.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00815217
Start Date
February 1 2009
End Date
May 1 2011
Last Update
July 29 2024
Active Locations (1)
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1
Veterans Affairs Medical Center, Washington D.C.
Washington D.C., District of Columbia, United States, 20422