Diabetic WoundsNCT00815217
The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers
A study testing injection of lipoaspirate in people with Diabetic Wounds and Venous Stasis Wounds, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Wounds, Venous Stasis Wounds
- What is being tested?
- injection of lipoaspirate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center, Washington D.C.
Washington D.C., District of Columbia, 20422
About this study
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.
Read the 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.
- Conditions
- Diabetic Wounds, Venous Stasis Wounds
- Being tested
- injection of lipoaspirate, control
- Keywords
- Lipoaspirate, Diabetes Mellitus, Mesenchymal Stem cells, Fat grafts, venous stasis
- Medical subject headings
- Diabetes Mellitus, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of lipoaspirateProcedure or surgery
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.
controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 lipoaspirate | Experimental | wounds which have received the lipoaspirate Receives: 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. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound measurements, healing of wounds, pictures of wounds
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionMay 2011 (estimated)
Why it stopped: due to PI work schedule and no personnel resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815217
- Sponsor's protocol ID
- 01194
- Status last verified
- Jul 2024
- First submitted
- 24 Dec 2008
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers
- ClinicalTrials.gov ID
- NCT00815217
- Acronym / sponsor ID
- 01194
- Conditions
- Diabetic Wounds, Venous Stasis Wounds
- Keywords
- Lipoaspirate, Diabetes Mellitus, Mesenchymal Stem cells, Fat grafts, venous stasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to PI work schedule and no personnel resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 lipoaspirate | Experimental | Procedure: injection of lipoaspiratewounds which have received the lipoaspirate |
| 2 control | Placebo comparator | Other: controlFor 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with the following criteria will be excluded:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of lipoaspirateSmall 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. | Procedure or surgery | 1 lipoaspirate |
| controlFor 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 | 2 control |
Primary outcome
wound measurements, healing of wounds, pictures of wounds
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of lipoaspirate in people with Diabetic Wounds and Venous Stasis Wounds, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound measurements, healing of wounds, pictures of wounds (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.