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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

Completed Phase 3 Last updated 28 June 2017
What this trial tests

Phase 3 trial testing BioChaperone PDGF-BB in Diabetic Foot Ulcer in 252 participants. Completed in 1 August 2016.

Timeline
1 December 2014
Primary endpoint
1 August 2016
1 August 2016

Quick facts

Lead sponsorAdocia
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment252
Start date1 December 2014
Primary completion1 August 2016
Estimated completion1 August 2016
Sites32 locations across India

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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
  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:

Other recruiting trials for Diabetic Foot Ulcer

Currently open trials in the same condition.

Other Adocia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing