Venous Leg UlcerPhase 4NCT06826339
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.
A Phase 4 study testing ACApatch™ and caregraFT™ in people with Venous Leg Ulcer and Venous Leg, run by Tiger Biosciences, LLC. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Venous Leg Ulcer, Venous Leg, Diabetic Foot
- What is being tested?
- ACApatch™ and caregraFT™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to Dec 2027
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 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.
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- 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 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.
- The potential subject must be at least 21 years of age or older.
- At enrollment, the potential subjects 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.
Who cannot join
- 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 believes will interfere with wound healing (e.g., biologics).
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- 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 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 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 time the potential subject received SOC.
- 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.
- 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 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 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 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 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 time the potential subject received SOC.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madison Dunn contact
United States1 site, 1 recruiting
- Recruiting
Serena Group
Monroeville, Pennsylvania, 15146
Laura Serena, 412-212-0123, lserena@serenagorups.com
About this study
Official 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.
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.
Read the detailed description
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
- Conditions
- Venous Leg Ulcer, Venous Leg, Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Ulcer Foot
- Being tested
- ACApatch™, caregraFT™, Standard of Care
- Medical subject headings
- Varicose Ulcer, Diabetic Foot, Foot Ulcer, Leg Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACApatch™Other
Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
caregraFT™Other
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DFU CAMP 1 + SOC = ACApatch™ + SOC | Experimental | ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue. Receives: Other: ACApatch™ |
| DFU CAMP 2 + SOC = caregraFT™ + SOC | Experimental | caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue. Receives: Other: caregraFT™ |
| DFU Standard of Care | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. Receives: Other: Standard of Care |
| VLU CAMP 1 + SOC = ACApatch™ + SOC | Experimental | ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue. Receives: Other: ACApatch™ |
| VLU CAMP 2 + SOC = caregraFT™ + SOC | Experimental | caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue. Receives: Other: caregraFT™ |
| VLU Standard of Care | Active comparator | Standard of care will be cleaning, debridement, and ulcer moisture balance. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The between-arm difference in subjects that complete wound closure
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. The platform design permits the inclusion of additional products by amending the protocol.
Measured: 1-12 Weeks
Secondary outcomes (4)
Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone.
Measured: 1-12 weeks
Percent Area Reduction
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone.
Measured: 1-12 weeks
VAS
To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4.
Measured: 1-12 Weeks
Adverse Events
To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone.
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 posted13 Feb 2025
- Study start6 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For a platform trial design, the allocation ratio is equal to the square root of the number of Intervention groups. This study will include 4 Intervention groups and 2 Control groups. A treatment effect of 0.35, significance level of 5%, 80% power, and a 1.4:1:1 for the VLU platform and 1.4:1:1 ratio for the DFU platform.
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826339
- Sponsor's protocol ID
- TIGERCAMP
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06826339
- Acronym / sponsor ID
- TIGERCAMP
- Conditions
- Venous Leg Ulcer, Venous Leg, Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Ulcer Foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
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.
Detailed description
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- For a platform trial design, the allocation ratio is equal to the square root of the number of Intervention groups. This study will include 4 Intervention groups and 2 Control groups. A treatment effect of 0.35, significance level of 5%, 80% power, and a 1.4:1:1 for the VLU platform and 1.4:1:1 ratio for the DFU platform.
| Arm | Type | Receives |
|---|---|---|
| DFU CAMP 1 + SOC = ACApatch™ + SOC | Experimental | Other: ACApatch™ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue. |
| DFU CAMP 2 + SOC = caregraFT™ + SOC | Experimental | Other: caregraFT™caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue. |
| DFU Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
| VLU CAMP 1 + SOC = ACApatch™ + SOC | Experimental | Other: ACApatch™ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue. |
| VLU CAMP 2 + SOC = caregraFT™ + SOC | Experimental | Other: caregraFT™caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue. |
| VLU Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, and ulcer moisture balance. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects 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.
Key exclusion criteria (37 listed)
- 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.
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 |
|---|---|---|
| ACApatch™Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU CAMP 1 + SOC = ACApatch™ + SOC, VLU CAMP 1 + SOC = ACApatch™ + SOC |
| caregraFT™Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU CAMP 2 + SOC = caregraFT™ + SOC, VLU CAMP 2 + SOC = caregraFT™ + SOC |
| Standard of CareBeginning 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 | DFU Standard of Care, VLU Standard of Care |
Primary outcome
The between-arm difference in subjects that complete wound closure
Time frame: 1-12 Weeks
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. The platform design permits the inclusion of additional products by amending the protocol.
4 secondary outcomes
Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure
Time frame: 1-12 weeks
Percent Area Reduction
Time frame: 1-12 weeks
VAS
Time frame: 1-12 Weeks
Adverse Events
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 22 Sep 2026.
- 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.
Madison Dunn contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACApatch™ and caregraFT™ in people with Venous Leg Ulcer and Venous Leg, run by Tiger Biosciences, LLC. 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 27 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 22 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arshdeep Kaur, MS (1-888-665-5005, arshdeep.kaur@sientra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The between-arm difference in subjects that complete wound closure (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 22 Sep 2026.