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 of the Forefoot.

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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) of the forefoot.

Targeted Conditions

Study Overview

Start Date
January 23, 2023
Completion Date
June 30, 2025
Enrollment
60
Date Posted
September 14, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Perseverance Research Center, LLC
Scottsdale, Arizona 85254, United States

NEA Baptist Clinic
Jonesboro, Arkansas 72401, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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 diabetic foot osteomyelitis (DFO) of the forefoot as evidenced by at least 3 out of 5 of the following:

Positive PTB (probe-to-bone) 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
Participant who requires surgical debridement OR Participant who requires amputation of a toe where osteomyelitis is considered to be not fully resected and extends into the metatarsal head.
Participant is male or female
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance in from enrollment up to Week 52.
Participant is capable of giving signed informed consent

Exclusion Criteria:

Osteomyelitis of the most distal aspect of the distal phalanx (toe tip)
Osteomyelitis in any location other than the forefoot
Amputation of the proximal or distal phalanx of the great toe where osteomyelitis is completely contained within the amputated segment
Acute amputation site (< 30 days post-operatively)
Ulcers present for more than 12 months duration
Significant peripheral arterial disease: Ankle brachial index ≤ 0.7 mm Hg OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg
Any significant immunocompromising disease
Evidence of systemic infection/sepsis associated with osteomyelitis of the forefoot
Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial
Any other type of infection that would require ongoing systemic antibiotic therapy during trial enrollment
History of muscular disorders, such as myasthenia gravis or parkinsonism
Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e. Hyperparathyroidism)
Immunologically suppressed or has received systemic administration of corticosteroids (does not include topical, inhaled or intranasal formulations) at a dose of >10 mg prednisone (or corticosteroid equivalent) for more than 14 consecutive days within the 90 days prior to informed consent
Concurrent involvement in a trial of another investigational product
Ulcers larger than 3.5 cm in diameter
Contra-indication for having a MRI scan
Inability to have a MRI scan
DFI defined as severe (grade 4) by the Infectious Diseases Society of America (IDSA) /International Working Group on the Diabetic Foot criteria.
Hemoglobin A1c (HbA1c) > 12%
Moderate to severe reduction in renal function, defined as estimated glomerular filtration rate (eGFR) of < 44.0 ml/min/1.73 m2 and creatinine ≥ 3.0 mg/dL
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 or allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (vancomycin), or aminoglycoside antibiotics (gentamicin)
The investigator believes trial participation may compromise safety of the participant or the results of the trial

Study Contact Info

Study Contact Name
Keira Watts, Clinical Project Manager; Nicole Villagomez, In-House CRA MCRA

Contact Listings Owner Form

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 of the Forefoot. 0 reviews

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05539963