ACTIVE_NOT_RECRUITING

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

Conditions

Diabetic Foot Osteomyelitis feasibility between-group effect size surgical debridement systemic antibiotic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-01-23

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05539963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Locations (Sites)

Titan Clinical Research

Mesa, Arizona, 85202

United States

Axsendo Clinical Research

Phoenix, Arizona, 85024

United States

Perseverance Research Center, LLC

Scottsdale, Arizona, 85253

United States

Advanced Footcare LLC

Scottsdale, Arizona, 85260

United States

NEA Baptist Clinic

Jonesboro, Arkansas, 72405

United States

Viable Clinical Research

Henderson, Nevada, 89014

United States

Equitable Health Partners - NJ

Mountainside, New Jersey, 07092

United States

Mount Sinai West

New York, New York, 10019

United States

UNC School Medicine

Chapel Hill, North Carolina, 27599

United States

Seaside Clinical Research Institute

Wilmington, North Carolina, 28412

United States

Collaborators and Investigators

Sponsor: Biocomposites Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-23

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-01-23

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

feasibility
between-group effect size
surgical debridement
systemic antibiotic

Additional Relevant MeSH Terms

Diabetic Foot Osteomyelitis