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Diabetic Foot UlcerPhase 4CAMPLIFENCT06562296

Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

A Phase 4 study testing Amnion-Intermediate-Chorion and Amnion-Chorion-Amnion in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Cellution Biologics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers. Read more about this study

Who is it for?
Ages 18 to 98 years
Conditions the study is for
Diabetic Foot Ulcer, Venous Leg Ulcer
What is being tested?
Amnion-Intermediate-Chorion and Amnion-Chorion-Amnion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
4 sitesUnited States
Study dates
14 Oct 2024to 16 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

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 to 98 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
  • Subjects must be at least 18 years of age or older.
  • Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
  • At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 5.0 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.
  • The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
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  • The target ulcer must be 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.
  • 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 ≥ 0.7 and ≤ 1.3;
  • TBI ≥ 0.6;
  • TCOM ≥ 40 mmHg;
  • PVR: biphasic.
  • If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  • The subject must consent to using the prescribed off-loading method for the duration of the study.
  • The subject must agree to attend the weekly study visits required by the protocol.
  • The subject must be willing and able to participate in the informed consent process.
  • Potential subjects are required to meet all the following criteria for enrollment in the study.
  • Subjects must be at least 21 years of age or older.
  • At randomization 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 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

  • Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
  • A subject known to have a life expectancy of < 6 months is excluded.
  • The subject is excluded if the target ulcer is not secondary to diabetes.
  • If the target ulcer is infected or if there is cellulitis in the surrounding skin.
  • If there is evidence of osteomyelitis complicating the target ulcer.
  • Subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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  • A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
  • The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
  • A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
  • The subject is excluded if 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).
  • Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
  • The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.
  • A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
  • A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
  • Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
  • A subject with end stage renal disease requiring dialysis is excluded.
  • A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
  • A subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.
  • A subject with a known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics is excluded.
  • Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
  • Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.
  • 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). MolecuLight 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.
  • A subject with a known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics is excluded.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Sure Step Foot & Ankle

    Cincinnati, Ohio, 45249

  • Symphony Research

    Jacksonville, Florida, 32257

  • Family Foot & Ankle

    Kenosha, Wisconsin, 53142

  • RGV Wound Care Group

    Weslaco, Texas, 78596

Other trials in United States

About this study

Official title: Multicenter, Prospective, Randomized Controlled Matriarch Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus SOC Alone of Nonhealing Diabetic Foot and Venous Leg Ulcers

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Read the detailed description

Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SOC) treatment and frequently become infected.

Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

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.

Being tested
Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care
Keywords
diabetic foot ulcer, venous leg ulcer, DFU, VLU, ulcer
Medical subject headings
Diabetic Foot, Varicose Ulcer, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amnion-Intermediate-ChorionOther

    Also called AIC

    Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

  • Amnion-Chorion-AmnionOther

    Also called ACA

    Dehydrated human placental trilayer allograft derived from donated human tissue.

  • Standard of CareProcedure or surgery

    Also called SOC

    Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

Study groups in NCT06562296
Study groupRoleWhat they receive
AIC for DFUsExperimentalParticipants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and 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.
Receives: Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care
AIC for VLUsExperimentalParticipants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product derived from donated human tissue, and 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.
Receives: Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care
ACA for DFUsExperimentalParticipants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer human placental tissue derived from donated human tissue, and 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.
Receives: Other: Amnion-Chorion-Amnion; Procedure: Standard of Care
ACA for VLUsExperimentalParticipants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product derived from donated human tissue, and 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.
Receives: Other: Amnion-Chorion-Amnion; Procedure: Standard of Care
Standard of CareActive comparatorBeginning 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.
Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of ulcers with complete wound closure

    The percentage of DFU and VLU target ulcers achieving complete wound closure. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.

    Measured: 1-12 weeks

Secondary outcomes (5)

  1. Time to complete closure for ulcer

    Time to closure will be determined for each treatment group and compared to Standard Of Care. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.

    Measured: 1-12 weeks

  2. Percentage of wound area change for target ulcer

    Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic planimetry and physical examination.

    Measured: 1-12 weeks

  3. Incidence of Adverse events

    The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit.

    Measured: 1-12 weeks

  4. Changes to pain associated with the target ulcer

    Change in pain in the target ulcer assessed using the Visual Analog Scale (VAS) from week 1 to week 12. VAS is a tool that uses a 0-10 (no to extreme pain) point scale to measure pain intensity.

    Measured: 1-12 weeks

  5. Determine changes in Quality of Life

    Changes in quality of life using both the Wound Quality of Life (wQOL) and Forgotten Wound Score (FWS) questionnaires that measure the health-related quality of life (HRQoL) of patients with chronic wounds.

    wQOL questionnaire is scored using a 5-point Likert scale, where 0 means "not at all" and 4 means "very much". Higher scores indicate greater impairment of quality of life. Higher the score indicates lower quality of life. [Time Frame: Visits 1, 4, 8, and 12/Final Visit].

    FWS questionnaire measures 12 activities scored 0-4. Responses are summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. Higher the score indicates lower quality of life. [Time Frame: Visits 1, 4, 8, and 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.

  1. First posted20 Aug 2024
  2. Study start14 Oct 2024
  3. Primary completion11 Jun 2025
  4. Study completion16 Jan 2026

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562296
Sponsor's protocol ID
CELLBIO-2024-001
Acronym
CAMPLIFE
Status last verified
Apr 2026
First submitted
12 Aug 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amnion-Intermediate-Chorion and Amnion-Chorion-Amnion in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Cellution Biologics at 4 sites 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 39 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of ulcers with 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?

On the ClinicalTrials.gov record for NCT06562296.

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 13 Apr 2026.

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CAMPLIFE Clinical Trial NCT06562296 | AzTrials