Diabetic FootNCT06550596
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
A study testing Axolotl DualGraft + SOC in people with Diabetic Foot and Ulcer Foot, run by Axolotl Biologix at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) 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 Foot, Foot Ulcer
- What is being tested?
- Axolotl DualGraft + SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to Oct 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 1.0 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.
- 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:
- 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 offloading 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 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 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 Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit 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
Performance Foot and Ankle Specialists
Thousand Oaks, California, 91320
Dr. Patel, 805-380-3152, info@performancefa.com
About this study
Official title: A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Read the detailed description
AXOCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Conditions
- Diabetic Foot, Ulcer Foot, Foot Ulcer, Diabetic Foot Ulcer
- Being tested
- Standard of Care, Axolotl DualGraft + SOC
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Dehydrated Human Amnion Membrane (dhAM), Vascular Diseases, Leg Ulcer, Ulcer leg, Skin Ulcer, Diabetes Complications, Diabetes Mellitus, Diabetic Neuropathies, Foot Diseases, Diabetic Foot, Foot Ulcer, Ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Vascular Diseases, Leg Ulcer, Skin Ulcer, Diabetes Complications, Diabetes Mellitus, Diabetic Neuropathies
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.
Axolotl DualGraft + SOCOther
Participants will receive weekly applications of Axolotl DualGraft 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 |
| Axolotl DualGraft + SOC | Experimental | Axolotl DualGraft is a dehydrated human amnion membrane. Receives: Other: Axolotl DualGraft + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of dhAM + SOC vs SOC
To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.
Measured: 1-12 Weeks
Secondary outcomes (5)
Time to closure for the target ulcer
To determine the proportion of ulcers that heal over 12 weeks for dhAM plus SOC versus SOC alone (Time to closure).
Measured: 1-12 weeks
Percent area reduction
To determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.
Measured: 1-12 weeks
Adverse events
To demonstrate a reduction in adverse events in subjects receiving dhAM plus SOC versus SOC alone.
Measured: 1-12 Weeks
Determine improvement in quality of life using Wound Quality of Life questionnaire
Quality of Life is assessed using the Wound Quality of Life (wQOL) checklist at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC.
Measured: 1-12 weeks
Determine improvement in quality of life using Forgotten Wound Score questionnaire
Quality of life is assessed using the Forgotten Wound Score (FWS) at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC.
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 Aug 2024
- Study start23 Sep 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- AXOLCAMP is a multi-center, open label, randomized controlled trial to determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers. over 12 weeks.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axolotl Biologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550596
- Sponsor's protocol ID
- AXOLCAMP
- Status last verified
- Jan 2025
- First submitted
- 5 Aug 2024
- Last updated
- 30 Jan 2025
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06550596
- Acronym / sponsor ID
- AXOLCAMP
- Conditions
- Diabetic Foot, Ulcer Foot, Foot Ulcer, Diabetic Foot Ulcer
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Dehydrated Human Amnion Membrane (dhAM), Vascular Diseases, Leg Ulcer, Ulcer leg, Skin Ulcer, Diabetes Complications, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Axolotl BiologixIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 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.
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Detailed description
AXOCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AXOLCAMP is a multi-center, open label, randomized controlled trial to determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers. over 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
| Axolotl DualGraft + SOC | Experimental | Other: Axolotl DualGraft + SOCAxolotl DualGraft is a dehydrated human amnion membrane. |
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 1.0 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.
Key exclusion criteria (16 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 |
|---|---|---|
| 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 |
| Axolotl DualGraft + SOCParticipants will receive weekly applications of Axolotl DualGraft and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Axolotl DualGraft + SOC |
Primary outcome
Efficacy of dhAM + SOC vs SOC
Time frame: 1-12 Weeks
To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.
5 secondary outcomes
Time to closure for the target ulcer
Time frame: 1-12 weeks
Percent area reduction
Time frame: 1-12 weeks
Adverse events
Time frame: 1-12 Weeks
Determine improvement in quality of life using Wound Quality of Life questionnaire
Time frame: 1-12 weeks
Determine improvement in quality of life using Forgotten Wound Score questionnaire
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 30 Jan 2025.
- 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 Axolotl DualGraft + SOC in people with Diabetic Foot and Ulcer Foot, run by Axolotl Biologix 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 16 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 30 Jan 2025. 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 M 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?
Efficacy of dhAM + SOC vs SOC (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 30 Jan 2025.