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Compares treatment options for Venous Leg Ulcer
Official title Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
ClinicalTrials.gov ID: NCT06826339
What this study is testing
- What it's testing
- Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 weeks
- 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 21 and older
You may be able to join if
- (DFU)
- people The potential subject must be at least 21 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured...
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to...
You likely can't join if
- will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded...
- 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. Exclusion Criteria: (DFU)
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
See the full eligibility criteria
Who can join
- (DFU)
- people The potential subject must be at least 21 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
- The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.
- The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and
What rules you out
- will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
- 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. Exclusion Criteria: (DFU)
- 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 potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The potential subject's target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the potential subject's target ulcer.
- 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 surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). EKare Imaging Device is not required for...
- The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which...
- 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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- The potential subject has a wound with active or latent infection.
- The potential subject has a disorder that would create unacceptable risk of post-operative complication. Inclusion Criteria:(VLU)
- The potential subject must be at least 21 years of age or older.
- At enrollment, the potential people must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- The potential subject has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
- The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- 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. Exclusion Criteria: (VLU)
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The potential subject's target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the potential subject's target ulcer.
- 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 has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). EKare Imaging Device is not required for...
- The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which...
- 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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- The potential subject has a wound with active or latent infection.
- The subject has a disorder that would create unacceptable risk of post-operative complication.
The study team makes the final eligibility decision.
Where it's taking place
- Monroeville, Pennsylvania, 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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monroeville, Pennsylvania, 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.