STIMULAN VG for Bed Sores

(BLADE OPU2 Trial)

Recruiting at 3 trial locations

Overseen By Daniel Roberts

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biocomposites Ltd

Must not be taking: Recreational drugs, Narcotics, Alcohol

Disqualifiers: Substance abuse, Smoking, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called STIMULAN VG for severe bed sores, known as Stage IV pressure ulcers. It compares this treatment, which involves inserting STIMULAN VG (a type of medical device) into the ulcer, to the standard care of surgery and antibiotics. The trial targets individuals with serious bed sores requiring surgery and showing signs of bone infection. Those dealing with these deep sores and underlying bone infections might be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to understand any specific requirements.

Is there any evidence suggesting that STIMULAN VG is likely to be safe for humans?

Research has shown that STIMULAN VG is being tested in trials to determine its safety and effectiveness for treating severe pressure ulcers, also known as bed sores. Unfortunately, detailed safety information from earlier studies is unavailable. Since this treatment is in phase 2 trials, initial safety tests have already been completed, and the treatment has demonstrated a reasonable level of safety in humans so far.

This phase focuses on understanding how well people can tolerate the treatment and identifying any side effects. If STIMULAN VG had been unsafe in earlier stages, it would not have progressed to this phase. Although being in a phase 2 trial does not guarantee the absence of side effects, it indicates that the treatment is considered safe enough for more detailed study in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about STIMULAN VG for treating bed sores because it offers a new approach by combining ulcer bursectomy and debridement with the insertion of a specialized material directly into the ulcer cavity. This material, STIMULAN VG, is unique because it can be inserted directly into the wound site, potentially enhancing healing by delivering targeted treatment where it's needed most. Unlike standard care, which primarily focuses on cleaning and closing the wound, STIMULAN VG could provide a more direct and sustained method to aid recovery and prevent infection. This innovative approach might lead to faster healing and better outcomes for patients with bed sores.

What evidence suggests that STIMULAN VG might be an effective treatment for bed sores?

Research shows that STIMULAN VG, which participants in this trial may receive, may help treat bone infections in patients with severe bed sores. In earlier studies, patients who received STIMULAN VG had better results than those who only received standard care. This treatment delivers antibiotics directly into the sore, potentially increasing effectiveness against the infection. While more research is needed, early findings suggest that STIMULAN VG could be a promising option for those with serious pressure ulcers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe stage IV pressure ulcers and bone infection (osteomyelitis) confirmed by MRI or CT scan. Candidates must need surgery involving excision, bony debridement, and flap coverage, and be able to follow the study's procedures. Exclusion criteria are not specified.

Inclusion Criteria

I am mentally and physically capable of following the study's requirements.

Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures

I am eligible for surgery to repair my wound with skin flaps or direct closure.

Exclusion Criteria

I cannot follow bedrest or specific movement restrictions.

Severe immunologically compromised patients as determined by the clinician

Diabetic patient with Hba1C level above 9

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ulcer bursectomy, debridement, and receive either STIMULAN VG insertion or standard of care with peri-operative antibiotics

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on wound closure and healing

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• STIMULAN VG

Trial Overview The trial compares STIMULAN VG combined with systemic antibiotics and surgical debridement against standard care which includes only systemic antibiotics and surgical debridement. The goal is to see if STIMULAN VG improves treatment outcomes for osteomyelitis in patients with stage IV pressure ulcers.

How Is the Trial Designed?

Group I: Interventional STIMULAN VG Experimental Treatment 2 Interventions

Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap/primary closure. Peri-operative antibiotics.

Group II: Standard of Care (SoC) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Biocomposites Ltd

Lead Sponsor

Trials

6

Recruited

270+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1. withpower.com withpower.com/trial/stimulan-vg-for-bed-sores-babcb

STIMULAN VG for Bed Sores (BLADE OPU2 Trial) The goal is to see if STIMULAN VG improves treatment outcomes for osteomyelitis in patients with stage IV pressure ulcers. How Is the Trial Designed? 2 ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/biocomposites-initiates-two-phase-ii-trials-of-stimulan-vg-in-us/

Biocomposites initiates two-Phase II trials of STIMULAN VG ... The BLADE-VG2 and BLADE-OPU2 trials will investigate STIMULAN VG for patients with diabetic foot osteomyelitis and stage IV pressure ulcers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06283979

A Randomized Controlled Phase II Trial of STIMULAN VG ... 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 ...

4. biocomposites.com biocomposites.com/news/biocomposites-announces-two-new-phase-ii-clinical-trials-of-stimulan-vg-a-calcium-matrix-antibiotic-carrier-mixed-with-vancomycin-and-gentamicin-in-the-u-s/

Biocomposites Announces Two New Phase II Clinical Trials Biocomposites is now recruiting patients to its BLADE-VG2 trial, which will evaluate the safety and efficacy of STIMULAN VG in treating diabetic foot ...

5. trialx.com trialx.com/clinical-trials/listings/297996/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/?&radius=10&place=A&user_country=Concord%20N

Clinical Research Trial Listing ( Stage IV | Osteomyelitis 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 ...

6. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2805/multi-center-randomized-11-controlled/

A multi-center randomized (1:1) controlled phase 2 trial of ... New life-saving treatments for Pressure ulcers in clinical trial on A multi-center randomized (1:1) controlled phase 2 trial of STIMULAN VG with debridement ...