Diabetic Foot UlcerCAMPAIGNNCT06600724
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
A study testing EPIEFFECT and EPIXPRESS in people with Diabetic Foot Ulcer and Diabetic Foot, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus
- What is being tested?
- EPIEFFECT and EPIXPRESS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2024to Aug 2026
- Phase
- Interventional
- 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 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.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm^2 and a maximum surface area of 5.0 cm^2 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.
- 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.
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- 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:
- Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
- Toe-Brachial Index (TBI) ≥ 0.6;
- Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
- Pulse Volume Resistance (PVR): biphasic.
- If the potential 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.
- 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.
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 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.
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- 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 is taking hydroxyurea.
- 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 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 2-week screening phase: the 2 weeks from the initial screening visit (S1) 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.
- Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- 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 potential 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 aminoglycoside antibiotics is excluded.
Trial locations and contacts
1 site in 1 country.
Thomas Serena, MD contact
United States1 site, 1 recruiting
- Recruiting
SerenaGroup - Monroeville
Monroeville, Pennsylvania, 15146
Laura Serena, 412-212-0123, LSerena@serenagroups.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Read the detailed description
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers. The study will evaluate two products, EPIEFFECT® and EPIXPRESS™, which are both ppLHACMs.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer, Diabetic, Foot Ulcer
- Being tested
- Standard of Care, EPIEFFECT, EPIXPRESS
- Keywords
- Ulcer, Foot Ulcer, Diabetic Foot Ulcer, Foot
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EPIEFFECTOther
Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
EPIXPRESSOther
Participants will receive weekly applications of EPIXPRESS 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 | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. Receives: Other: Standard of Care |
| EPIEFFECT | Experimental | EPIEFFECT® is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. Receives: Other: EPIEFFECT |
| EPIXPRESS | Experimental | EPIXPRESS™ is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. EPIXPRESS is fenestrated to help facilitate fluid movement and can be used on wounds that produce copious amounts of exudate. Receives: Other: EPIXPRESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of target ulcers achieving wound closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Measured: 1 - 12 weeks
Secondary outcomes (4)
Percent of wound closure area
Percentage wound area reduction from treatment visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
Measured: 1 - 12 weeks
Adverse Events
Number of adverse events will be evaluated weekly
Measured: 1 - 12 weeks
Change in Pain in Target Ulcer
Change in pain in the target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale
Measured: 1 - 12 weeks
Change in Quality of Life
Change in quality-of-life using the Wound Quality of Life (wQOL) questionnaire
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 posted19 Sep 2024
- Study start27 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CAMPAIGN uses a Prospective Modified Platform Multicenter Randomized Controlled Clinical Trial design.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, SerenaGroup, Inc.Dennis McMahon, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600724
- Sponsor's protocol ID
- MIMEDX001
- Acronym
- CAMPAIGN
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06600724
- Acronym / sponsor ID
- CAMPAIGN / MIMEDX001
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer, Diabetic, Foot Ulcer
- Keywords
- Ulcer, Foot Ulcer, Diabetic Foot Ulcer, Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 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.
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Detailed description
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers. The study will evaluate two products, EPIEFFECT® and EPIXPRESS™, which are both ppLHACMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- CAMPAIGN uses a Prospective Modified Platform Multicenter Randomized Controlled Clinical Trial design.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
| EPIEFFECT | Experimental | Other: EPIEFFECTEPIEFFECT® is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. |
| EPIXPRESS | Experimental | Other: EPIXPRESSEPIXPRESS™ is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. EPIXPRESS is fenestrated to help facilitate fluid movement and can be used on wounds that produce copious amounts of exudate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm^2 and a maximum surface area of 5.0 cm^2 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.
Key exclusion criteria (23 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 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.
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 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 | Standard of Care |
| EPIEFFECTParticipants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first | Other | EPIEFFECT |
| EPIXPRESSParticipants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first | Other | EPIXPRESS |
Primary outcome
Percentage of target ulcers achieving wound closure
Time frame: 1 - 12 weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks.
4 secondary outcomes
Percent of wound closure area
Time frame: 1 - 12 weeks
Adverse Events
Time frame: 1 - 12 weeks
Change in Pain in Target Ulcer
Time frame: 1 - 12 weeks
Change in Quality of Life
Time frame: 1 - 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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. This study is not recruiting at the moment.
Thomas Serena, MD contact
Thomas Serena, MD principal investigator
SerenaGroup, Inc.
Dennis McMahon, MD study director
MiMedx Group, 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 EPIEFFECT and EPIXPRESS in people with Diabetic Foot Ulcer and Diabetic Foot, run by MiMedx Group, Inc. 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 16 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany Bonafide (888-960-1343, bbonafide@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of target ulcers achieving 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 19 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.