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

July 25, 2024 updated by: Washington D.C. Veterans Affairs Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 abnormal capillaries, stem cell treatment which can aid in angiogenesis and cellular signaling may be a treatment option which is aimed directly at the root cause of the disease.

Aim 1: 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.

Rationale: Despite considerable effort, successful healing of diabetic lower extremity wounds and venous stasis wounds remain as a difficult therapeutic challenge. We will examine whether autologous lipoaspirate injection is a safe and effective treatment option for diabetic lower extremity wounds and venous stasis wounds.

Hypothesis: Injection of lipoaspirate subcutaneously around diabetic wounds and venous stasis wounds will promote wound healing more effectively than conventional treatments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center, Washington D.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 lipoaspirate
wounds which have received the lipoaspirate
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.
Placebo Comparator: 2 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
wound measurements, healing of wounds, pictures of wounds
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington D.C. Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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