Diabetic FootSVFDPNNCT07553468
Stromal Vascular Cells for the Treatment of Diabetic Peripheral Neuropathy
A study testing Adipose-derived Stromal Vascular Fraction Cells in people with Diabetic Foot and Diabetic Peripheral Neuropathy, run by Michael H Carstens at 1 site in Nicaragua.
Trial summary
This is an interventional open-label study to determine the safety and clinical performance of SVF cells in the treatment of Diabetic Peripheral Neuropathy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Foot, Diabetic Peripheral Neuropathy
- What is being tested?
- Adipose-derived Stromal Vascular Fraction Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNicaragua
- Study dates
- 1 Dec 2024to 31 Mar 2026
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable diabetes
- Presence of DPN as documented reductions in sensory perception threshold (SPT) and/or vibration perception threshold below protective levels
- Capacity to understand and provide informed consent.
Who cannot join
- Presence of a disease prohibitive of surgical intervention
- Smoking and/or substance abuse within 3 months of the onset of the study
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Hospital Escuela Oscar Danilo Rosales Argüello
León, León Department, 21000
About this study
Official title: Treatment of Diabetic Peripheral Neuropathy With Adipose-derived Stromal Vascular Fraction Cells
This is an interventional open-label study to determine the safety and clinical performance of SVF cells in the treatment of Diabetic Peripheral Neuropathy.
Read the detailed description
The burden of diabetes mellitus (DM) is a global socio-economic burdern affecting an estimate 578 million (M) people by 2030 and consuming 10% of world health care expenditures. Sequelae of diabetes are seen in the distal extremities, the most common being peripheral neuropathy (DPN) affecting up to 50% of patients within the first 10 years of the disease. Painful neuropathy is present in 20-30% of patients and is resistant to pharmaceutical treatments such as tricyclics antidepressants, anticonvulsants, serotonin reuptake inhibitors, and opioids. No FDA-approved therapies with disease-modifying activity currently exist. In over 50% of patients DPN follows a progressive course characterized initially by loss of pedal sensation, predisposing to failure to perceive traumatic injuries with consequent ulceration and the threat of limb loss.
Several types of adult derived mesenchymal sromal/stem (sic) cells have been used for the treatment of DFUs with varied results based on their anti-inflammatory, anti-fibrotic and tissue repair properties. Adipose tissue provides a readily accessible sources of MSCs; these cells can be isolated from the adipose structural components after liposuction and subsequently cultured. Drawbacks of AD-MSCs include the cost of Good Manufacturing Practice culure/manufacturing, time of manufacturing and potential allergic reactions, if the cell prduct comes from an allogeneic source. An alternative to cultured/manufactured AD-MSC is an AD-MSC containing product, stromal vascular fraction (SVF), that can be obtained and delivered as a point-of-care intervention.
SVF has been shown to secrete numerous growth factors and cytokines, including vascular endothelial growth factor, transforming growth factor-1 and hepatocyte growth factor, and interferon-gamma and IL-10. In addition, SVF has been shown to induce M2 macrophages, further driving an anti-inflammatory environment. SVF has been used in multiple clinical trials to treat diabetic foot ulcers, peripheral vascular disease, burn wounds, radiation injury and Crohn's disease fistula, among other disease states. SVF has been used in the United States under a Food and Drug Administration investigational device exemption to treat knee osteoarthritis (safe and with evidence of potential efficacy) and is currently in a pivotal clinical trial ("150 subjects) for that indication.
In previous publications regarding treatment of chronic wounds due to diabetes and ischemia anecdotal evidence of long-term improvements in sensation were noted. For this reason this additional study was designed to investigate the clinical of using SVF cells for the treatment of DPN.
- Conditions
- Diabetic Foot, Diabetic Peripheral Neuropathy
- Being tested
- Adipose-derived Stromal Vascular Fraction Cells
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived Stromal Vascular Fraction CellsBiological
Also called SVF
Administration to the DFU / ankle was performed at four injection sites:
- 20 cc into the wound bed
- 20 cc subcutaneously around the perimeter of the wound
- 10 cc along the tibialis posterior pathway at the ankle prior to entry into the plantar surface
- 10 cc along the tibialis anterior / dorsalis pedis pathway from the ankle to the dorsum of the foot.
| Study group | Role | What they receive |
|---|---|---|
| Foot ulcer and leg neuropathy | Experimental | The intervention at the foot being carried out by administrating a standardized dose of 50 million SVF cells suspended in Lactated Ringer's (LR) solution for a total volume of 60cc. Receives: Biological: Adipose-derived Stromal Vascular Fraction Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Ulcer Healing
Percent closure based on changes in ulcer size dimensions in square cm.
Measured: Baseline, 4, 12, 24, and 48 weeks post treatment.
Secondary outcomes (2)
Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes
Semmes-Weinstein scores to document sensation threshold
Measured: Baseline, 4, 12, 24, and 48 weeks post treatment.
Vibration: Documenting diabetes-associated lower extremity pathophysiology changes
Horwell neurothesiometer scores to document vibration threshold
Measured: Baseline, 4, 12, 24, and 48 weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Dec 2024
- Primary completion28 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael H Carstens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth A Bertram, MD, PhD, Study director, Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USAMichael H Carstens, MD, Principal investigator, Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553468
- Sponsor's protocol ID
- DVS-DSG-CJST-0205-12-2025
- Acronym
- SVFDPN
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amos PJ, Shang H, Bailey AM, Taylor A, Katz AJ, Peirce SM. IFATS collection: The role of human adipose-derived stromal cells in inflammatory microvascular remodeling and evidence of a perivascular phenotype. Stem Cells. 2008 Oct;26(10):2682-90. doi: 10.1634/stemcells.2008-0030. Epub 2008 Apr 24.
PubMed 18436860Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.
PubMed 23570660Bura A, Planat-Benard V, Bourin P, Silvestre JS, Gross F, Grolleau JL, Saint-Lebese B, Peyrafitte JA, Fleury S, Gadelorge M, Taurand M, Dupuis-Coronas S, Leobon B, Casteilla L. Phase I trial: the use of autologous cultured adipose-derived stroma/stem cells to treat patients with non-revascularizable critical limb ischemia. Cytotherapy. 2014 Feb;16(2):245-57. doi: 10.1016/j.jcyt.2013.11.011.
PubMed 24438903Carstens MH, Gomez A, Cortes R, Turner E, Perez C, Ocon M, Correa D. Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells. Stem Cell Res. 2017 Jan;18:14-21. doi: 10.1016/j.scr.2016.12.001. Epub 2016 Dec 8.
PubMed 27984756Carstens MH, Mendieta M, Perez C, Villareal E, Garcia R. Assisted Salvage of Ischemic Fasciocutaneous Flap Using Adipose-Derived Mesenchymal Stem Cells: In-Situ Revascularization. Aesthet Surg J. 2017 Jul 1;37(suppl_3):S38-S45. doi: 10.1093/asj/sjx052.
PubMed 29025216
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Diabetic Peripheral Neuropathy With Adipose-derived Stromal Vascular Fraction Cells
- ClinicalTrials.gov ID
- NCT07553468
- Acronym / sponsor ID
- SVFDPN / DVS-DSG-CJST-0205-12-2025
- Conditions
- Diabetic Foot, Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Michael H CarstensUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Apr 2026 (actual)
- 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.
This is an interventional open-label study to determine the safety and clinical performance of SVF cells in the treatment of Diabetic Peripheral Neuropathy.
Detailed description
The burden of diabetes mellitus (DM) is a global socio-economic burdern affecting an estimate 578 million (M) people by 2030 and consuming 10% of world health care expenditures. Sequelae of diabetes are seen in the distal extremities, the most common being peripheral neuropathy (DPN) affecting up to 50% of patients within the first 10 years of the disease. Painful neuropathy is present in 20-30% of patients and is resistant to pharmaceutical treatments such as tricyclics antidepressants, anticonvulsants, serotonin reuptake inhibitors, and opioids. No FDA-approved therapies with disease-modifying activity currently exist. In over 50% of patients DPN follows a progressive course characterized initially by loss of pedal sensation, predisposing to failure to perceive traumatic injuries with consequent ulceration and the threat of limb loss.
Several types of adult derived mesenchymal sromal/stem (sic) cells have been used for the treatment of DFUs with varied results based on their anti-inflammatory, anti-fibrotic and tissue repair properties. Adipose tissue provides a readily accessible sources of MSCs; these cells can be isolated from the adipose structural components after liposuction and subsequently cultured. Drawbacks of AD-MSCs include the cost of Good Manufacturing Practice culure/manufacturing, time of manufacturing and potential allergic reactions, if the cell prduct comes from an allogeneic source. An alternative to cultured/manufactured AD-MSC is an AD-MSC containing product, stromal vascular fraction (SVF), that can be obtained and delivered as a point-of-care intervention.
SVF has been shown to secrete numerous growth factors and cytokines, including vascular endothelial growth factor, transforming growth factor-1 and hepatocyte growth factor, and interferon-gamma and IL-10. In addition, SVF has been shown to induce M2 macrophages, further driving an anti-inflammatory environment. SVF has been used in multiple clinical trials to treat diabetic foot ulcers, peripheral vascular disease, burn wounds, radiation injury and Crohn's disease fistula, among other disease states. SVF has been used in the United States under a Food and Drug Administration investigational device exemption to treat knee osteoarthritis (safe and with evidence of potential efficacy) and is currently in a pivotal clinical trial ("150 subjects) for that indication.
In previous publications regarding treatment of chronic wounds due to diabetes and ischemia anecdotal evidence of long-term improvements in sensation were noted. For this reason this additional study was designed to investigate the clinical of using SVF cells for the treatment of DPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot ulcer and leg neuropathy | Experimental | Biological: Adipose-derived Stromal Vascular Fraction CellsThe intervention at the foot being carried out by administrating a standardized dose of 50 million SVF cells suspended in Lactated Ringer's (LR) solution for a total volume of 60cc. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically stable diabetes
- Presence of DPN as documented reductions in sensory perception threshold (SPT) and/or vibration perception threshold below protective levels
- Capacity to understand and provide informed consent.
Key exclusion criteria (2 listed)
- Presence of a disease prohibitive of surgical intervention
- Smoking and/or substance abuse within 3 months of the onset of the study
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 |
|---|---|---|
| Adipose-derived Stromal Vascular Fraction CellsAlso: SVFAdministration to the DFU / ankle was performed at four injection sites: 1. 20 cc into the wound bed 2. 20 cc subcutaneously around the perimeter of the wound 3. 10 cc along the tibialis posterior pathway at the ankle prior to entry into the plantar surface 4. 10 cc along the tibialis anterior / dorsalis pedis pathway from the ankle to the dorsum of the foot. | Biological | Foot ulcer and leg neuropathy |
Primary outcome
Foot Ulcer Healing
Time frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Percent closure based on changes in ulcer size dimensions in square cm.
2 secondary outcomes
Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes
Time frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Vibration: Documenting diabetes-associated lower extremity pathophysiology changes
Time frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 18436860Amos PJ, Shang H, Bailey AM, Taylor A, Katz AJ, Peirce SM. IFATS collection: The role of human adipose-derived stromal cells in inflammatory microvascular remodeling and evidence of a perivascular phenotype. Stem Cells. 2008 Oct;26(10):2682-90. doi: 10.1634/stemcells.2008-0030. Epub 2008 Apr 24.
- Background: PubMed 23570660Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.
- Background: PubMed 24438903Bura A, Planat-Benard V, Bourin P, Silvestre JS, Gross F, Grolleau JL, Saint-Lebese B, Peyrafitte JA, Fleury S, Gadelorge M, Taurand M, Dupuis-Coronas S, Leobon B, Casteilla L. Phase I trial: the use of autologous cultured adipose-derived stroma/stem cells to treat patients with non-revascularizable critical limb ischemia. Cytotherapy. 2014 Feb;16(2):245-57. doi: 10.1016/j.jcyt.2013.11.011.
- Background: PubMed 27984756Carstens MH, Gomez A, Cortes R, Turner E, Perez C, Ocon M, Correa D. Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells. Stem Cell Res. 2017 Jan;18:14-21. doi: 10.1016/j.scr.2016.12.001. Epub 2016 Dec 8.
- Background: PubMed 29025216Carstens MH, Mendieta M, Perez C, Villareal E, Garcia R. Assisted Salvage of Ischemic Fasciocutaneous Flap Using Adipose-Derived Mesenchymal Stem Cells: In-Situ Revascularization. Aesthet Surg J. 2017 Jul 1;37(suppl_3):S38-S45. doi: 10.1093/asj/sjx052.
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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.
Kenneth A Bertram, MD, PhD study director
Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA
Michael H Carstens, MD principal investigator
Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose-derived Stromal Vascular Fraction Cells in people with Diabetic Foot and Diabetic Peripheral Neuropathy, run by Michael H Carstens at 1 site in Nicaragua.
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 2 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: finished, as of the sponsor's last update on 28 Apr 2026. 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 Nicaragua. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Foot Ulcer Healing (time frame: Baseline, 4, 12, 24, and 48 weeks post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553468, which also lists 5 linked publications.
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 28 Apr 2026.