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NCT02236793
Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and Control Group Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
Phase 3 trial testing BioChaperone PDGF-BB in Diabetic Foot Ulcer in 252 participants. Completed in 1 August 2016.
1 August 2016
Quick facts
| Lead sponsor | Adocia |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 252 |
| Start date | 1 December 2014 |
| Primary completion | 1 August 2016 |
| Estimated completion | 1 August 2016 |
| Sites | 32 locations across India |
Drugs / interventions tested
- BioChaperone PDGF-BB — full drug profile →
- Standard of Care
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
Adocia — full company profile →
Who can join
18 and older, any sex, with Diabetic Foot Ulcer. 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.
-
Incidence of complete wound closure.
Time frame: 20 weeks
Sponsor's own description
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Chronic Diabetic Wounds and Their Treatment with Skin Substitutes.
Holl J, Kowalewski C, Zimek Z, Fiedor P, et al · · 2021 · cited 205× · PMID 33804192 · DOI 10.3390/cells10030655 -
Neurotrophic factors for disease-modifying treatments of Parkinson's disease: gaps between basic science and clinical studies.
Chmielarz P, Saarma M. · · 2020 · cited 40× · PMID 32700249 · DOI 10.1007/s43440-020-00120-3 -
Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.
Hao ZW, Zhang ZY, Wang ZP, Wang Y, et al · · 2024 · cited 24× · PMID 39639374 · DOI 10.1186/s40779-024-00576-x
Verify or expand the search:
- PubMed search for NCT02236793
- 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
Other Adocia trials
Trials by the same sponsor.
- NCT05373186 — A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections · Phase 1 · completed
- NCT05373199 — A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects Wi · Phase 1 · completed
- NCT05373212 — A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes · Phase 1 · completed
- NCT04816890 — A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM) · Phase 2 · completed
- NCT04501107 — A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in P · Phase 1 · completed
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 NCT02236793 (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 Adocia
- Last refreshed: 28 June 2017
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/NCT02236793.
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