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NCT02943486: MSCDTDFU
Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
Phase 1/Phase 2 trial testing dac-MSCs in Foot Ulcer, Diabetic in 51 participants. Status unknown.
1 June 2018
Quick facts
| Lead sponsor | Universidad Autónoma de Bucaramanga |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 January 2017 |
| Primary completion | 1 June 2018 |
| Estimated completion | 1 January 2019 |
Drugs / interventions tested
- dac-MSCs
- MSCs — full drug profile →
- Fitostimoline — full drug profile →
Conditions studied
- Foot Ulcer, Diabetic — all drugs for Foot Ulcer, Diabetic →
Sponsor
Universidad Autónoma de Bucaramanga — full company profile →
Who can join
Adults 40 to 80, any sex, with Foot Ulcer, Diabetic. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Wound size change
Time frame: One year
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
Sponsor's own description
The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
MSCs and their exosomes: a rapidly evolving approach in the context of cutaneous wounds therapy.
Marofi F, Alexandrovna KI, Margiana R, Margiana R, et al · · 2021 · cited 47× · PMID 34863308 · DOI 10.1186/s13287-021-02662-6 -
A meta-analysis on application and prospect of cell therapy in the treatment of diabetes mellitus.
Li H, Chen C, Wang Y, Yi W, et al · · 2025 · cited 3× · PMID 40390031 · DOI 10.1186/s13287-025-04377-4
Verify or expand the search:
- PubMed search for NCT02943486
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Foot Ulcer, Diabetic
Currently open trials in the same condition.
- NCT06487780 — Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers · NA · recruiting
- NCT05586542 — Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers · Phase 1 · active not recruiting
- NCT04210089 — Total Contact Soft Cast in Diabetic Foot Ulcers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02943486 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Autónoma de Bucaramanga
- Last refreshed: 21 October 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02943486.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing