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Tests treatment safety and results for Diabetic Foot
Official title A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT07159282
What this study is testing
- What it's testing
- A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
You likely can't join if
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
See the full eligibility criteria
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI...
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and was not assigned by chance to the SOC only arm.
- The potential subject participated in the CAMPX trial and achieved complete closure.
The study team makes the final eligibility decision.
Where it's taking place
- Hollywood, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hollywood, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.