NCT05539963 (BLADE-VG2) is a Phase 2 clinical trial of STIMULAN VG in Diabetic Foot Osteomyelitis, sponsored by Biocomposites Ltd.

Who is sponsoring NCT05539963?

NCT05539963 is sponsored by Biocomposites Ltd.

What drugs are being tested in NCT05539963?

Interventions in NCT05539963: STIMULAN VG, Systemic Antibiotics.

What condition does NCT05539963 study?

NCT05539963 studies Diabetic Foot Osteomyelitis.

Is NCT05539963 still recruiting?

NCT05539963 is currently active, enrolled. Last updated 24 June 2025.

Last reviewed 2025-06-24 · How we verify

NCT05539963: BLADE-VG2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis

Active, enrolled Phase 2 Last updated 24 June 2025

What this trial tests

Phase 2 trial testing STIMULAN VG in Diabetic Foot Osteomyelitis in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 January 2023

Primary endpoint
20 June 2025

30 December 2025

Quick facts

Lead sponsor	Biocomposites Ltd
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	23 January 2023
Primary completion	20 June 2025
Estimated completion	30 December 2025
Sites	10 locations across United States

Drugs / interventions tested

STIMULAN VG — full drug profile →
Systemic Antibiotics — full drug profile →

Conditions studied

Diabetic Foot Osteomyelitis — all drugs for Diabetic Foot Osteomyelitis →

Sponsor

Biocomposites Ltd — full company profile →

Who can join

18 and older, any sex, with Diabetic Foot Osteomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of STIMULAN VG

Trials testing the same drug.

NCT06283979 — A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Assoc · Phase 2 · recruiting
NCT06808568 — Expanded Access Program (EAP) STIMULAN VG · available

Other recruiting trials for Diabetic Foot Osteomyelitis

Currently open trials in the same condition.

NCT06010433 — CERAMENT G Device Registry · recruiting

Other Biocomposites Ltd trials

Trials by the same sponsor.

NCT06283979 — A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Assoc · Phase 2 · recruiting
NCT06808568 — Expanded Access Program (EAP) STIMULAN VG · available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05539963 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biocomposites Ltd
Last refreshed: 24 June 2025

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/NCT05539963.

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