Pathologic ProcessesC5CAMPNCT06674980
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
A study testing AM/Single - DFU, AM/Double - DFU and AM/Single - VLU in people with Pathologic Processes and Diabetes Mellitus, run by C5 Biomedical at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders
- What is being tested?
- AM/Single - DFU, AM/Double - DFU and AM/Single - VLU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to 22 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age or older.
- Must have diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
- Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
- Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- 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 ulcer may not include exposed tendon or bone.
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- 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 subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.
- Subject must consent to using the prescribed offloading method for the duration of the study.
- Subject must agree to attend weekly study visits.
- Subject must be willing and able to participate in the consent process.
- Potential subjects are required to meet all the following criteria for enrollment in the study.
- Subjects must be at least 18 years of age or older.
- At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
- The 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.
Who cannot join
- Subject is known to have a life expectancy of < 6 months.
- Subject's target ulcer is not secondary to diabetes.
- Target ulcer is infected or there is cellulitis in the surrounding skin.
- Target ulcer exposes tendon or bone.
- Evidence of osteomyelitis complicating the target ulcer.
- Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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- The 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 believes will interfere with wound healing (e.g., biologics).
- Subject is taking hydroxyurea.
- Subject has applied topical steroids to the ulcer surface within one month of initial screening.
- Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the 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). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.
- Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.
- Subject has end stage renal disease requiring dialysis.
- Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.
- Subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- The potential subject is known to have a life expectancy of < 6 months.
- The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the 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 believes will interfere with wound healing (e.g., biologics).
- 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 target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- The surface area measurement of the 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 time the potential subject received SOC.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- Participation 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 subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- A subject has a wound with active or latent infection is excluded.
- A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Poirot Podiatry
Metairie, Louisiana, 70001
Donna Belette, 504-919-3668, dbelette@serenagroups.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
Read the detailed description
The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Disease, Diabetic Angiopathies
- Being tested
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU, Standard of Care - VLU, AM/Single - VLU
- Keywords
- Human Placental Membrane (HPM), Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Cellular, Acellular, and Matrix-like Product (CAMP), Cellular and/or Tissue-Based Product (CTP)
- Medical subject headings
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care - DFUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Single - DFUOther
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - DFUOther
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of Care - VLUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Single - VLUOther
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - VLUOther
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care - DFU | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC). Receives: Other: Standard of Care - DFU |
| AM/Single - DFU | Experimental | AM/Single is an air-dried, sterile single layer human amniotic membrane allograft. Receives: Other: AM/Single - DFU |
| AM/Double - DFU | Experimental | AM/Double is an air-dried, sterile double layer human amniotic membrane allograft. Receives: Other: AM/Double - DFU |
| Standard of Care - VLU | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps. Receives: Other: Standard of Care - VLU |
| AM/Single - VLU | Experimental | AM/Single is an air-dried, sterile single layer human amniotic membrane allograft. Receives: Other: AM/Single - VLU |
| AM/Double - VLU | Experimental | AM/Double is an air-dried, sterile double layer human amniotic membrane allograft. Receives: Other: AM/Double - VLU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.
The proportion of subjects achieving complete wound closure of target ulcer.
Measured: 1-12 weeks
Secondary outcomes (5)
Time to closure for target ulcer.
Length of time in days to closure will be determined for each treatment group and compared to SOC alone.
Measured: 1-12 weeks
Percent Area Reduction (PAR)
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Measured: 1-12 weeks
Adverse Events
Determine number of adverse events
Measured: 1-12 weeks
Change in pain in target ulcer
Change in pain in target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale
Measured: 1-12 weeks
Determine improvement in quality of life
Quality of life assessed using the Wound Quality of Life (wQOL) at TV-1, TV-4, TV-8, TV-12 / Final Visit
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start20 Dec 2024
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C5 Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674980
- Sponsor's protocol ID
- Pro00082457
- Acronym
- C5CAMP
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
- ClinicalTrials.gov ID
- NCT06674980
- Acronym / sponsor ID
- C5CAMP / Pro00082457
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Disease, Diabetic Angiopathies
- Keywords
- Human Placental Membrane (HPM), Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Cellular, Acellular, and Matrix-like Product (CAMP), Cellular and/or Tissue-Based Product (CTP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- C5 BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
Detailed description
The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard of Care - DFU | Active comparator | Other: Standard of Care - DFUDebridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC). |
| AM/Single - DFU | Experimental | Other: AM/Single - DFUAM/Single is an air-dried, sterile single layer human amniotic membrane allograft. |
| AM/Double - DFU | Experimental | Other: AM/Double - DFUAM/Double is an air-dried, sterile double layer human amniotic membrane allograft. |
| Standard of Care - VLU | Active comparator | Other: Standard of Care - VLUDebridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps. |
| AM/Single - VLU | Experimental | Other: AM/Single - VLUAM/Single is an air-dried, sterile single layer human amniotic membrane allograft. |
| AM/Double - VLU | Experimental | Other: AM/Double - VLUAM/Double is an air-dried, sterile double layer human amniotic membrane allograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- At least 18 years of age or older.
- Must have diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
- Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
- Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
Key exclusion criteria (37 listed)
- Subject is known to have a life expectancy of < 6 months.
- Subject's target ulcer is not secondary to diabetes.
- Target ulcer is infected or there is cellulitis in the surrounding skin.
- Target ulcer exposes tendon or bone.
- Evidence of osteomyelitis complicating the target ulcer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care - DFUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Standard of Care - DFU |
| AM/Single - DFUParticipants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | AM/Single - DFU |
| AM/Double - DFUParticipants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | AM/Double - DFU |
| Standard of Care - VLUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Standard of Care - VLU |
| AM/Single - VLUParticipants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | AM/Single - VLU |
| AM/Double - VLUParticipants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | AM/Double - VLU |
Primary outcome
Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.
Time frame: 1-12 weeks
The proportion of subjects achieving complete wound closure of target ulcer.
5 secondary outcomes
Time to closure for target ulcer.
Time frame: 1-12 weeks
Percent Area Reduction (PAR)
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-12 weeks
Change in pain in target ulcer
Time frame: 1-12 weeks
Determine improvement in quality of life
Time frame: 1-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Serena, MD principal investigator
SerenaGroup, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AM/Single - DFU, AM/Double - DFU and AM/Single - VLU in people with Pathologic Processes and Diabetes Mellitus, run by C5 Biomedical at 1 site 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 29 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Rogers (888-960-1343 ext. 1008, Brogers@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks. (time frame: 1-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.