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

NCT00815217 | Withdrawn

• 1 other identifier: 01194
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Wounds; Venous Stasis Wounds

Keywords

Lipoaspirate; Diabetes Mellitus; Mesenchymal Stem cells; Fat grafts; venous stasis

Outcome Measures

Primary Outcomes (1)

• wound measurements, healing of wounds, pictures of wounds

  1 year

Study Arms (2)

1 lipoaspirate

EXPERIMENTAL

wounds which have received the lipoaspirate

Procedure: injection of lipoaspirate

2 control

PLACEBO COMPARATOR

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.

Other: control

Interventions

injection of lipoaspirate PROCEDURE

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.

1 lipoaspirate

control OTHER

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.

2 control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead

Study Sites (1)

Veterans Affairs Medical Center, Washington D.C.

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Varicose Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 29, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2011
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

US (1)