Chronic Wounds & Ulcers: cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 53 registered records for Chronic Wounds & Ulcers — 3 recruiting, 7 at Phase 3 or 4, in 17 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
The registry entries here centre on diabetic foot ulcers, where impaired healing reflects neuropathy, ischaemia and infection together. Cell and vesicle products aim to restore a functional healing environment. This is one of the few areas with a genuine regulatory precedent for advanced wound products, so evidence standards are comparatively well defined.
Therapy classes side by side
Counts come from separate registry queries per class; a study testing two interventions can appear in more than one row, so rows do not sum to the all-interventions total.
Geography of the research
United States accounts for about 33% of country mentions among sampled studies; 17 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| United States | 13 |
| China | 11 |
| South Korea | 4 |
| Germany | 3 |
| Spain | 2 |
| Israel | 2 |
| Turkey (Türkiye) | 1 |
| Australia | 1 |
The largest registered studies
Sorted by planned enrolment — size is not quality, but a 300-participant trial can answer questions a 12-participant series cannot.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02796079 — A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
| NCT02831075 — A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
| NCT02834858 — Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications | Phase 1 | Unknown | 240 | Jie Shen | 2016-01 |
| NCT06681428 — Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | n/a | Recruiting | 240 | Tides Medical | 2024-11-14 |
| NCT04176120 — Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) | Phase 3 | Completed | 220 | BioTissue Holdings, Inc | 2020-07-01 |
| NCT02264288 — Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD. | Phase 2 | Terminated | 159 | Celularity Incorporated | 2014-10-23 |
Most recently registered
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07686094 — Placental Cells for Diabetic Foot Ulcers | n/a | Not Yet Recruiting | n/a | Wake Forest University Health Sciences | 2026-10 |
| NCT07498218 — Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue | n/a | Recruiting | n/a | Ayu, Inc. | 2026-03-11 |
| NCT06843122 — Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL) | n/a | Not Yet Recruiting | n/a | Medical University of Warsaw | 2025-03-08 |
| NCT06846476 — The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters | n/a | Completed | n/a | Medipol University | 2024-12-24 |
| NCT06681428 — Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | n/a | Recruiting | n/a | Tides Medical | 2024-11-14 |
Reading this honestly
Registration counts measure activity, not effect. A study appears here the moment it is registered — before any participant is enrolled, and regardless of whether results are ever posted. For Chronic Wounds & Ulcers specifically, the practical question is which registered study — if any — matches the product a provider is offering, and what its outcome measures actually are.
Frequently asked
How many stem-cell trials exist for Chronic Wounds & Ulcers?
53 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 3 were recruiting.
Which therapy class is furthest along for Chronic Wounds & Ulcers?
Ranked by Phase 3/4 records: PRP (3), MSC (2), HSCT (1), exosomes (0).
Does a recruiting trial mean I can be treated?
No. Trials have eligibility criteria, and joining one is not the same as buying a treatment. Paying a clinic for an unproven intervention outside a registered study gives you neither the protections nor the data collection of a trial.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.