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The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers

NCT00815217 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Diabetic Wounds
  • Venous Stasis Wounds

Interventions

PROCEDURE

injection of lipoaspirate

Small volume lipoaspiration will be performed. This technique involves harvesting small amounts of fat by making a small incision in the donor site (usually the abdomen) and infiltrating 25-75cc of tumescence solution (1 liter of LR, 30 cc of 1% lidocaine, 1 ampule of 1:1,000,000 epinepherine) into the adipose layer with a blunt infiltrator. The Coleman aspiration Cannulae, approximately 2-3 mm in diameter and 15 cm in length attached with a Luer-Lok suction syringe will be used to harvest up to 100 cc of fat. Gently pulling back on the syringe provides a small amount of negative pressure to allow for aspiration into the syringe.For the intervention wound, the adipose tissue will be implanted using the infiltration Cannulae (blunt end, 7 cm- COL-17) or the both approx. 1mm in diameter. The implantation will be in single tunnels radially around each wound spaced at 5-10 mm apart and approximately 3 - 5 cm in length.

OTHER

control

For the control wound, only the sterile injectable tumescence solution (1 liter of LR, 30 cc of 1% lidocaine, 1 ampule of 1:1,000,000 epinepherine) will be used. The solution will be injected in a similar fashion with single tunnels radially around the control wound spaced at 5-10 mm apart and approximately 3 - 5 cm in length.

Sponsors & Collaborators

  • Washington D.C. Veterans Affairs Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815217 on ClinicalTrials.gov