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NCT04723134
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
Phase 2 trial testing Folinic acid calcium salt in Diabetic Foot Ulcer in 15 participants. Completed in 24 September 2024.
24 September 2024
Quick facts
| Lead sponsor | Joseph Boykin, MD |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 December 2021 |
| Primary completion | 24 September 2024 |
| Estimated completion | 24 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Folinic acid calcium salt
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
Joseph Boykin, MD
Who can join
18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic foot ulcer (ES-DFU) wounds. Male and female Veterans with type-2 diabetes mellitus and chronic ES-DFUs acceptable to the study inclusion/exclusion criteria will be considered for enrollment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
RJX Improves Wound Healing in Diabetic Rats.
Uckun FM, Orhan C, Tuzcu M, Durmus AS, et al · · 2022 · cited 7× · PMID 35721744 · DOI 10.3389/fendo.2022.874291 -
Folinic Acid Improves Healing of Diabetic Foot Ulcers.
Hoke GD, Stone A, Bauer MA, Carter WC, et al · · 2026 · PMID 41795141 · DOI 10.1111/wrr.70141
Verify or expand the search:
- PubMed search for NCT04723134
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot Ulcer
Currently open trials in the same condition.
- NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
- NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of 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 NCT04723134 (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 Joseph Boykin, MD
- Last refreshed: 4 October 2024
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/NCT04723134.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing