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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.

NCT06283979 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

Conditions

  • Pressure Ulcer, Stage IV
  • Osteomyelitis

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.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Biocomposites Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283979 on ClinicalTrials.gov