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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

Pressure Ulcer, Stage IV Osteomyelitis

RECRUITING PHASE2

Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

NCT06262854

Diabete Mellitus Foot Ulcer Osteomyelitis - Foot +1 more

NOT_YET_RECRUITING NA

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

NCT02833389

Neuropathic Diabetic Foot Ulcers

COMPLETED PHASE1

Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy

NCT05076955

Diabetic Foot Ulcer

UNKNOWN EARLY_PHASE1

Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

NCT00312364

Foot Ulcer, Diabetic Diabetes Complications

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This trial is an open-label, multi-center, randomized, controlled feasibility trial.

All participants will undergo surgical debridement and receive either STIMULAN VG and an abbreviated course of systemic antibiotic therapy (3 days ±2 days) or a full course (4-6 weeks) of systemic antibiotic therapy.

The total duration of study is Approximately 55 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Osteomyelitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STIMULAN VG

Participants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.

Group Type EXPERIMENTAL

STIMULAN VG

Intervention Type DRUG

Participants will receive STIMULAN VG via implantation during debridement surgery on Day 1.

Systemic Antibiotics

Intervention Type DRUG

Participants will receive Antibiotics per site-specific requirements.

Standard of Care

Participants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.

Group Type ACTIVE_COMPARATOR

Systemic Antibiotics

Intervention Type DRUG

Participants will receive Antibiotics per site-specific requirements.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STIMULAN VG

Participants will receive STIMULAN VG via implantation during debridement surgery on Day 1.

Intervention Type DRUG

Systemic Antibiotics

Participants will receive Antibiotics per site-specific requirements.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participants are eligible to be included in the trial only if all of the following criteria apply:

1. Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
2. Participant has a current diagnosis and is being treated for diabetes mellitus, type 1 or type 2
3. 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:

1. Positive PTB test
2. Presence of draining sinus presumed to be from underlying bone
3. Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis
4. Ulcer present for greater than 30 days
5. 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)
4. Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement
5. All genders are eligible to participate if they are not pregnant, not breastfeeding, are not of childbearing potential or they agree to follow contraceptive guidance
6. Subject or legal authorized representative able to provide, voluntary, signed and dated informed consent prior to any study related procedures

Exclusion Criteria

Participants are excluded from the trial if any of the following criteria apply:

1. Osteomyelitis in any location other than the foot (i.e. excluding any bones located proximal to the foot)
2. Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes
3. Charcot foot or other deformities where the investigator believes adequate offloading is not possible
4. Severe diabetic foot infection (grade 4) in accordance to IDSA/IWGDF criteria (Appendix 6)
5. Moderate to severe reduction in renal function, defined as estimated glomerular filtration rate (eGFR) of \< 30.0 ml/min/1.73 m2 (Formula for calculating eGFR: 2021 CKD-EPI Creatinine).
6. Significant peripheral arterial disease:

* Ankle brachial index ≤ 0.7 mm Hg OR
* toe pressure ≤ 40 mm Hg OR
* transcutaneous oximetry ≤ 40 mm Hg
7. Hemoglobin A1c (HbA1c) \> 12%
8. Contra-indication or inability to undergo an MRI scan
9. Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial
10. Participant who is severely immunocompromised or has received high dose corticosteroids (\>10 mg prednisone (or corticosteroid equivalent) for more than 14 consecutive days within the 90 days prior to informed consent)
11. Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism)
12. Patients with active COVID-19 will be excluded from enrollment until they are able to undergo the surgical procedure
13. Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that, in the judgment of the investigator, may compromise the ability of the trial participant to adhere to the trial conduct and procedures
14. Previous history of adverse incidents, allergy or contra indications (e.g. Myathesia Gravis) to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (vancomycin), or aminoglycoside antibiotics (gentamicin)
15. Concurrent involvement in a trial of another investigational product
16. The Investigator believes trial participation may compromise safety of the participant or the results of the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No