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Diabetic Foot OsteomyelitisPhase 2BLADE-VG2NCT05539963

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

A Phase 2 study testing STIMULAN VG and Systemic Antibiotics in people with Diabetic Foot Osteomyelitis, run by Biocomposites Ltd at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Osteomyelitis
What is being tested?
STIMULAN VG and Systemic Antibiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
10 sitesUnited States
Study dates
23 Jan 2023to 23 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are eligible to be included in the trial only if all of the following criteria apply:
  • 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
Show all 12Show fewer
  • 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)
  • Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement
  • 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
  • Subject or legal authorized representative able to provide, voluntary, signed and dated informed consent prior to any study related procedures

Who cannot join

  • Participants are excluded from the trial if any of the following criteria apply:
  • 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
  • Charcot foot or other deformities where the investigator believes adequate offloading is not possible
  • Severe diabetic foot infection (grade 4) in accordance to IDSA/IWGDF criteria (Appendix 6)
  • 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).
Show all 20Show fewer
  • Significant peripheral arterial disease:
  • Ankle brachial index ≤ 0.7 mm Hg OR
  • toe pressure ≤ 40 mm Hg OR
  • transcutaneous oximetry ≤ 40 mm Hg
  • Hemoglobin A1c (HbA1c) > 12%
  • Contra-indication or inability to undergo an MRI scan
  • Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial
  • 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)
  • Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism)
  • Patients with active COVID-19 will be excluded from enrollment until they are able to undergo the surgical procedure
  • 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
  • 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)
  • Concurrent involvement in a trial of another investigational product
  • The Investigator believes trial participation may compromise safety of the participant or the results of the trial

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • UNC School Medicine

    Chapel Hill, North Carolina, 27599

  • Viable Clinical Research

    Henderson, Nevada, 89014

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72405

  • Titan Clinical Research

    Mesa, Arizona, 85202

  • Equitable Health Partners - NJ

    Mountainside, New Jersey, 07092

  • Mount Sinai West

    New York, New York, 10019

  • Axsendo Clinical Research

    Phoenix, Arizona, 85024

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253

  • Advanced Footcare LLC

    Scottsdale, Arizona, 85260

  • Seaside Clinical Research Institute

    Wilmington, North Carolina, 28412

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Controlled Feasibility Trial of STIMULAN VG and Debridement With an Abbreviated Course of Systemic Antibiotics to Debridement and a Full Course of Systemic Antibiotics for the Treatment of Diabetic Foot Osteomyelitis

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).

Read the detailed description

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.

Being tested
STIMULAN VG, Systemic Antibiotics
Keywords
feasibility, between-group effect size, surgical debridement, systemic antibiotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STIMULAN VGDrug

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

  • Systemic AntibioticsDrug

    Participants will receive Antibiotics per site-specific requirements.

Study groups in NCT05539963
Study groupRoleWhat they receive
STIMULAN VGExperimentalParticipants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.
Receives: Drug: STIMULAN VG; Drug: Systemic Antibiotics
Standard of CareActive comparatorParticipants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.
Receives: Drug: Systemic Antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Confirmed absence of clinical signs of osteomyelitis or surgical site infection at the index site will be evidenced by Negative Probe to Bone Test (PTB), absence of draining sinus presumed to be from underlying bone and MRI scan at Week 24.

    Measured: Week 24

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

    Need for further antibiotic therapy for infection at the index site will be assessed at Week 24.

    Measured: Week 24

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

    Need for further additional surgical procedure or debridement to treat infection at the index site will be assessed at Week 24.

    Measured: Week 24

Secondary outcomes (10)

  1. Ulcer healing per the University of Texas (UT) Staging System for Diabetic Foot Ulcers

    The Investigator will assess the ulcer for healing using the UT Staging System for Diabetic Foot Ulcers which grades DFUs by grade (0, I, II, III) and stage (A, B, C, D), depending on the presence or absence of infection and ischemia. The grades are referred to as follows: grade 0 (pre-or post-ulcerative site that has healed), grade 1 (superficial ulcer not involving tendon, capsule, or bone), and grade 2 (ulcer penetrating to tendon or capsule), and grade 3 (ulcer penetrating bone or joint). The patient will be scored based on Grade score and stage score together. Grade 0, stage A considered being low severity, and Grade 3, stage D considered to be more severe.

    Measured: Week 12

  2. Number of participants with occurrence of reinfection at the index site

    Number of participants with the occurrence of reinfection at the index site will be assessed via PTB, absence of draining sinus presumed to be from underlying bone and MRI at Week 52.

    Measured: Week 52

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

    Need for further antibiotic therapy for infection at the index site will be assessed at Week 52.

    Measured: Week 52

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

    Need for further additional surgical procedure or debridement to treat infection at the index site will be assessed at Week 52.

    Measured: Week 52

  5. Relative change from baseline in Cardiff Wound Impact Schedule (CWIS) quality of life assessment

    The CWIS is designed and validated to specifically assess the quality of life (QoL) of subjects with chronic wounds (leg ulcers and diabetic foot ulcers (DFU)). This questionnaire contains 47 items divided into four scales: demographic and clinical characteristics (3 items), global health-related quality of life (HRQoL) (1 item), satisfaction with HRQoL (1 item) and impact of the wound on lifestyle. This last scale includes 3 domains: social life (14 items in total, 7 related to stress and 7 to experience), wellbeing (7 items), and physical symptoms and everyday living (24 items in total, 12 related to stress and 12 to experience). All three domains are scored on a 5-point scale, from "not at all" to "always". Thus, the total score includes the patient's perception of the experience and the associated stress. The final score ranges from 0 (poorer QoL) to 100 points (higher QoL) where a high score indicates a positive rating

    Measured: Week 24

  6. Number of participants with adverse events

    The number of participants with adverse events will be assessed.

    Measured: Week 52

  7. Number of participants discontinuing therapy prematurely due to a treatment related event

    The number of participants discontinuing therapy prematurely due to a treatment-related event will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).

    Measured: Week 52

  8. Number of hospitalizations/re-hospitalizations as a result of treatment for osteomyelitis or ulceration at the index site

    The number of hospitalizations/re-hospitalizations as a result of treatment for osteomyelitis will be assessed during the course of the trial and recorded on the participants eCRF.

    Measured: Week 52

  9. Number of participants undergoing amputation at the index site

    The number of participants undergoing amputation at the index site will be assessed during the course of the trial and recorded on the participants eCRF.

    Measured: Week 52

  10. Number of systemic antibiotic free days since trial surgery

    The total number of days from Day 1 to week 24 without the use of antibiotics.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start23 Jan 2023
  3. Primary completion22 Jun 2026
  4. Study completion23 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539963
Sponsor's protocol ID
254915
Acronym
BLADE-VG2
Status last verified
Jun 2025
First submitted
12 Sep 2022
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STIMULAN VG and Systemic Antibiotics in people with Diabetic Foot Osteomyelitis, run by Biocomposites Ltd at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05539963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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