NCT06283979View on ClinicalTrials.gov

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
Pressure Ulcer, Stage IVOsteomyelitis
Interventions
COMBINATION_PRODUCT

STIMULAN VG

Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.

PROCEDURE

Standard of Care

Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.

Trial Locations (4)

11501

RECRUITING

NYU Langone Hospital - Long Island Clinical Research Center, Mineola

15219

RECRUITING

University of Pittsburgh, McGowan Institute for Regenerative Medicine, Pittsburgh

60611

RECRUITING

Northwestern University Feinberg School of Medicine, Chicago

85032

NOT_YET_RECRUITING

Advanced Foot Care, LLC, Phoenix

Sponsors

Lead Sponsor

Biocomposites Ltd
All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

Biocomposites Ltd

INDUSTRY

NCT06283979 - A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. | Biotech Hunter | Biotech Hunter