Diabetic Foot Ulcers (DFUs)NCT06767501
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
A study testing E-GRAFT ™ and FIBRACOL™ in people with Diabetic Foot Ulcers (DFUs), run by Skye Biologics Holdings, LLC at 1 site in United States.
Trial summary
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: Rate of wound closure Change in ulcer size over 12 weeks Any adverse events or reactions (side… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs)
- What is being tested?
- E-GRAFT ™ and FIBRACOL™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2024to Dec 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 diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.
- 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 full thickness on the foot or ankle that does not probe to bone.
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- Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
- TCOM ≥30 mmHg
- ABI between 0.7 and 1.3
- PVR: Biphasic
- TBI ˃0.6
- As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle.
- 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.
- Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
- 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.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
- 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.
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- A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
- If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
- The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Crosswhite contact
United States1 site, 1 recruiting
- Recruiting
Professional Education and Research Institute
Roanoke, Virginia, 24016
Charles M Zelen, DPM FACFAS
About this study
Official title: A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following:
- Rate of wound closure
- Change in ulcer size over 12 weeks
- Any adverse events or reactions (side effects)
- Changes in neuropathy (nerve damage)
- Change in pain levels
- Occurrence of infection
Read the detailed description
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of diabetic foot ulcers (DFUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft as the primary dressing. The primary endpoint is the percentage of patients that go on to complete closure of the target ulcer between the two groups: SOC with FIBRACOL™ or SOC with E-GRAFT™. Secondary endpoints include the proportion of subjects achieving complete wound closure of the target ulcer by the end of 12 weeks.
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Being tested
- E-GRAFT ™, FIBRACOL™
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-GRAFT ™Other
E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.
FIBRACOL™Device
510K FDA cleared Collagen alginate dressing
| Study group | Role | What they receive |
|---|---|---|
| SOC primary dressing with E-GRAFT ™ | Experimental | Participants receive standard of care with E-GRAFT™ Receives: Other: E-GRAFT ™ |
| SOC primary dressing with FIBRACOL™ | Active comparator | Participants receive standard of care with FIBRACOL™ Receives: Device: FIBRACOL™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of index ulcers "healed" at 12-weeks
Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements
Measured: 12-weeks
Secondary outcomes (4)
Time to healing within 12-weeks
Time to healing will be taken as the time of first assessment (i.e. before confirmation within two weeks) of complete healing.
Measured: 12-weeks
Percentage Area Reduction over12 week period
Digital imaging
Measured: 12-weeks
Changes in peripheral neuropathy
Semmes Weinstein with vibratory, scores
Measured: 12-weeks
Change in pain levels during trial
NPRS (Subject Pain Scale), 0-10: The number 0 represents "no pain," the number 5 represents "moderate pain", and the number 10 represents the "worst possible pain."
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start28 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 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 Ulcers (DFUs)Studies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skye Biologics Holdings, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M Zelen, DPM FACFAS, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767501
- Sponsor's protocol ID
- SKY-WP-DFU-02
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone
- ClinicalTrials.gov ID
- NCT06767501
- Acronym / sponsor ID
- SKY-WP-DFU-02
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Skye Biologics Holdings, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jan 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.
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following:
- Rate of wound closure
- Change in ulcer size over 12 weeks
- Any adverse events or reactions (side effects)
- Changes in neuropathy (nerve damage)
- Change in pain levels
- Occurrence of infection
Detailed description
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of diabetic foot ulcers (DFUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft as the primary dressing. The primary endpoint is the percentage of patients that go on to complete closure of the target ulcer between the two groups: SOC with FIBRACOL™ or SOC with E-GRAFT™. Secondary endpoints include the proportion of subjects achieving complete wound closure of the target ulcer by the end of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC primary dressing with E-GRAFT ™ | Experimental | Other: E-GRAFT ™Participants receive standard of care with E-GRAFT™ |
| SOC primary dressing with FIBRACOL™ | Active comparator | Device: FIBRACOL™Participants receive standard of care with FIBRACOL™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.
- 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 (15 listed)
- A subject known to have a life expectancy of < 6 months is excluded.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
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 |
|---|---|---|
| E-GRAFT ™E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. | Other | SOC primary dressing with E-GRAFT ™ |
| FIBRACOL™510K FDA cleared Collagen alginate dressing | Device | SOC primary dressing with FIBRACOL™ |
Primary outcome
Comparison of the proportion of index ulcers "healed" at 12-weeks
Time frame: 12-weeks
Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements
4 secondary outcomes
Time to healing within 12-weeks
Time frame: 12-weeks
Percentage Area Reduction over12 week period
Time frame: 12-weeks
Changes in peripheral neuropathy
Time frame: 12-weeks
Change in pain levels during trial
Time frame: 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 10 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.
Melissa Crosswhite contact
Charles M Zelen, DPM FACFAS principal investigator
Professional Education and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-GRAFT ™ and FIBRACOL™ in people with Diabetic Foot Ulcers (DFUs), run by Skye Biologics Holdings, 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 17 inclusion and 15 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 10 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 Adam Isaac, DPM ((301) 471-8378, aisaacdpm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportion of index ulcers "healed" at 12-weeks (time frame: 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 10 Jan 2025.