Diabetic Foot UlcerNCT06564831
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
A study testing SLAM + SOC and SOC in people with Diabetic Foot Ulcer and Diabetic Foot, run by Applied Biologics, LLC at 1 site in United States.
Trial summary
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers 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
- What is being tested?
- SLAM + SOC and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to Aug 2025
- 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
- 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 20.0 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.
- The target ulcer must be Wager 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:
- 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.
Who cannot join
- 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, the subject is excluded.
- If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
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- 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 potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- 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 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 potential 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 and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
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
Detroit Foot and Ankle
Clinton Township, Michigan, 48038
Lina Barman, 586-329-3895, info@detroitfa.com
(586) 329-3895
About this study
Official title: A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
Read the detailed description
XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers [13]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane [13]. The product is screened and tested in a Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds AATB criteria [13].
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU
- Being tested
- SLAM + SOC, SOC
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLAM + SOCOther
Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
SOCOther
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 |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. Receives: Other: SOC |
| SLAM + SOC | Experimental | Single layer amniotic membrane (SLAM) + SOC Receives: Other: SLAM + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of target ulcers achieving complete wound closure in 12 weeks.
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Measured: 1-12 Weeks
Secondary outcomes (5)
The time to heal for target ulcers.
Time to closure will be determined for each treatment group and compared to SOC.
Measured: 1-12 weeks
Wound Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using MolecuLight Imaging Device, and physical examination.
Measured: 1-12 weeks
Adverse Events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Measured: 1-14 Weeks
Change in pain in the target ulcer
Change in pain in the target ulcer assessed using the PEG (pain, enjoyment in life, and general pain) scale. [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit].
Measured: 1-12 weeks
Change in quality of life
Change in quality-of-life using the wQOL(Wound Quality of Life) questionnaire [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or 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 posted21 Aug 2024
- Study start20 Sep 2024
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (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
- The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564831
- Sponsor's protocol ID
- CAMPX
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2024
- Last updated
- 20 Nov 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06564831
- Acronym / sponsor ID
- CAMPX
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Applied Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 Aug 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.
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
Detailed description
XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers [13]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane [13]. The product is screened and tested in a Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds AATB criteria [13].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: SOCOther: Standard of Care Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
| SLAM + SOC | Experimental | Other: SLAM + SOCSingle layer amniotic membrane (SLAM) + SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 20.0 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.
Key exclusion criteria (17 listed)
- 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, the subject is excluded.
- If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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 |
|---|---|---|
| SLAM + SOCWeekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | SLAM + SOC |
| SOCBeginning 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 |
Primary outcome
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time frame: 1-12 Weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks.
5 secondary outcomes
The time to heal for target ulcers.
Time frame: 1-12 weeks
Wound Area Reduction
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-14 Weeks
Change in pain in the target ulcer
Time frame: 1-12 weeks
Change 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 20 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLAM + SOC and SOC in people with Diabetic Foot Ulcer and Diabetic Foot, run by Applied Biologics, 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 15 inclusion and 17 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 20 Nov 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?
The percentage of target ulcers achieving complete wound closure in 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 20 Nov 2024.