Active — Not RecruitingPhase 2

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

United States61 participantsStarted 2023-01-23

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
. Participant has a current diagnosis and is being treated for diabetes mellitus, type 1 or type 2
. Participant who has confirmed presence of DFO (to include all bones below the ankle including the talus and calcaneum) as evidenced by at least 3 out of 5 of the following:
. Positive PTB test
. Presence of draining sinus presumed to be from underlying bone
. Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis
. Ulcer present for greater than 30 days
. Substantially elevated serum marker for inflammation (e.g. ESR \>70 mm/hr and C-reactive protein \>14mg/L or at least 40% higher than upper limits of normal value used at the investigational site)

Exclusion criteria

. Osteomyelitis in any location other than the foot (i.e. excluding any bones located proximal to the foot)
. Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site

Timeframe: Week 24

Number of participants with no clinical need for further antibiotic therapy for infection at the index site

Timeframe: Week 24

Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site

Timeframe: Week 24

Trial details

NCT IDNCT05539963

SponsorBiocomposites Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-20

View on ClinicalTrials.gov More Diabetic Foot Osteomyelitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
. Participant has a current diagnosis and is being treated for diabetes mellitus, type 1 or type 2
. Participant who has confirmed presence of DFO (to include all bones below the ankle including the talus and calcaneum) as evidenced by at least 3 out of 5 of the following:
. Positive PTB test
. Presence of draining sinus presumed to be from underlying bone
. Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis
. Ulcer present for greater than 30 days
. Substantially elevated serum marker for inflammation (e.g. ESR \>70 mm/hr and C-reactive protein \>14mg/L or at least 40% higher than upper limits of normal value used at the investigational site)

Exclusion criteria

. Osteomyelitis in any location other than the foot (i.e. excluding any bones located proximal to the foot)
. Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes

What they're measuring

Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site

Timeframe: Week 24

Number of participants with no clinical need for further antibiotic therapy for infection at the index site

Timeframe: Week 24

Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site

Timeframe: Week 24