Chronic Diabetic Foot UlcersPhase 4NCT04457752
Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)
A Phase 4 study testing Dual Layer Amniotic Membrane (DLAM). Artacent® in people with Chronic Diabetic Foot Ulcers, run by SerenaGroup, Inc. at 16 sites in 2 countries.
Trial summary
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- Dual Layer Amniotic Membrane (DLAM). Artacent®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 1 Sep 2020to 31 Mar 2023
- 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 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 with the Tissue Analytics photographic planimetry App.
- 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 without exposed 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 between 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.
- Target ulcers located on the plantar aspect of the foot must be offloaded for at least 30 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.
- 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.
- If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit he/she is excluded.
- The subject is excluded if the surface area measurement of the Target ulcer decreases by 40% or more during the 4-week screening phase: the 4 weeks from the initial screening visit (SV1) 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 participated in a clinical trial involving treatment with an investigational product within the previous 30 days 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.
- A Subject is excluded if the MolecuLight Device shows a positive fluorescence image in the wound bed on TV1
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites, 13 recruiting
- Recruiting
Serena Group Baton Rouge
Baton Rouge, Louisiana, 70806
Thomas E Serena, MS, FACS, serena@serenagroups.com
Khristina Serena, kserena@serenagroups.com
- Recruiting
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, 44103
Windy Cole, DPM, drwec@yahoo.com
Stacey Coe, scoe3@kent.edu
- Recruiting
Hoosier Foot and Ankle
Fishers, Indiana, 46037
Cheri Britt, cheribhfa@outlook.com
James Vestile, DPM, jvestile@gmail.com
- Recruiting
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, 16226
Nicole Schrecengost, 724-664-3843, nschrecengost@serenagroups.com
Matthew Sabo, DPM
- Recruiting
Armstrong County Memorial Hospital - Wound Clinic
Kittanning, Pennsylvania, 16201
Bryan Doner, DO, DrDoner@dandpmedicalgroup.com
Nicole Schrecengost, LPN, nschrecengost@serenagroups.com
- Recruiting
Regional Infectious Disease and Infusion Center, Inc
La Grange, Georgia, 30240
Bhuvan Doneepudi, MS, bhuvan@nobadbugs.com
Ravi Kamepalli@nobadbugs.com
- Recruiting
New Hope Podiatry
Los Angeles, California, 90063
Francis Morfin, francis_morfin@yahoo.com
Demitric Lopez, demitriclopez@gmail.com
- Recruiting
Mount Sinai St. Luke's Hospital
New York, New York, 10025
Denise Alabi, Denise.Alabi@mountsinai.org
John Lantis, MD
- Recruiting
Opelousas Medical Research Consultants, LLC
Opelousas, Louisiana, 70570
Kerry Thibodeaux, MD, KerryThibodeaux1960@gmail.com
Marcus Speyrer, mspeyrer@thewoundtreatmentcenter.com
- Recruiting
Royal Research
Pembroke Pines, Florida, 33027
Yalily Perez, yalilyp@royalresearchcorp.com
Yaili Perez, yailip@royalresearchcorp.com
- Recruiting
Titan Research
Phoenix, Arizona, 85004
Kwadjo Walker, kwalker@viableresearch.org
Noreen Rana, nrana.alas@viableresearch.org
- Completed
Mt.Olympus Medical Research
Sugar Land, Texas, 77479
- Recruiting
Heal Foundation
Tulsa, Oklahoma, 74146
Lam Le, MD, lam.le@sjmc.org
Phil Salon, philbert.salon@gmail.com
- Completed
Pharma Research Associates
Westchester, Florida, 33155
- Recruiting
Martin Foot and Ankle
York, Pennsylvania, 17402
Beth Mincer, beth@martinfootandankle.com
Maria Kasper, DMP
Puerto Rico1 site
- Completed
Clinical Research Management Group
Coto Laurel, 00780
About this study
Official title: A Randomised Controlled Multicentre Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care Versus Standard of Care Alone in the Healing of Chronic Diabetic Foot Ulcers
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.
Read the detailed description
Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted the phrase, "time is tissue." This adage reminds clinicians that the longer a DFU remains open, the greater the risk of infection, major amputation and death. The diabetic with a foot ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3. Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15 billion dollars annually4.
In recent years, several clinical trials have demonstrated that products derived from human placental membranes promote the healing of DFUs5. Research has confirmed that growth factors present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6. All these factors are highly desirable properties in the healing of chronic DFUs.
A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA) potentially can increase the delivery of growth factors due to its double layer of amniotic membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at 12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy of DLAM in DFUs.
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- Dual Layer Amniotic Membrane (DLAM). Artacent®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Layer Amniotic Membrane (DLAM). Artacent®Biological
Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
| Study group | Role | What they receive |
|---|---|---|
| Dual Layer Amniotic Membrane (DLAM) + SOC | Active comparator | DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance). Receives: Biological: Dual Layer Amniotic Membrane (DLAM). Artacent® |
| Standard of Care | No intervention | Standard of Care: sharp debridement, offloading, and proper moisture balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
- The percentage of target ulcers achieving complete wound closure in 12 weeks
Measured: 1-12 weeks
Secondary outcomes (5)
Percentage Wound Area Reduction
- Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
Measured: 1-12 weeks
Adverse Events
The number of adverse events
Measured: 1-12 weeks
Percentage of time wearing offloading boot
- Compliance with a prescribed offloading boot measured as % of time wearing the boot
Measured: 1-12 Weeks
Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine
- Change in pain in the target ulcer assessed using the PEG scale. [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit]
Measured: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
Changes in bacterial Load
- Exploratory Endpoint: changes in bacterial load measured using fluorescence imaging
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 posted7 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2022
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dual Layer Amniotic Membrane (DLAM). Artacent® Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Tides Medical
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD,FACS, Principal investigator, Serena Group, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457752
- Sponsor's protocol ID
- HITIDE
- Status last verified
- Nov 2022
- First submitted
- 30 Jun 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Multicentre Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care Versus Standard of Care Alone in the Healing of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04457752
- Acronym / sponsor ID
- HITIDE
- Conditions
- Chronic Diabetic Foot Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Tides Medical
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Jul 2020 (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 Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.
Detailed description
Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted the phrase, "time is tissue." This adage reminds clinicians that the longer a DFU remains open, the greater the risk of infection, major amputation and death. The diabetic with a foot ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3. Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15 billion dollars annually4.
In recent years, several clinical trials have demonstrated that products derived from human placental membranes promote the healing of DFUs5. Research has confirmed that growth factors present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6. All these factors are highly desirable properties in the healing of chronic DFUs.
A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA) potentially can increase the delivery of growth factors due to its double layer of amniotic membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at 12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy of DLAM in DFUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dual Layer Amniotic Membrane (DLAM). Artacent® Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
| Arm | Type | Receives |
|---|---|---|
| Dual Layer Amniotic Membrane (DLAM) + SOC | Active comparator | Biological: Dual Layer Amniotic Membrane (DLAM). Artacent®DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance). |
| Standard of Care | No intervention | –Standard of Care: sharp debridement, offloading, and proper moisture balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 with the Tissue Analytics photographic planimetry App.
- 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 |
|---|---|---|
| Dual Layer Amniotic Membrane (DLAM). Artacent®Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers. | Biological | Dual Layer Amniotic Membrane (DLAM) + SOC |
Primary outcome
Complete Wound Closure
Time frame: 1-12 weeks
- The percentage of target ulcers achieving complete wound closure in 12 weeks
5 secondary outcomes
Percentage Wound Area Reduction
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-12 weeks
Percentage of time wearing offloading boot
Time frame: 1-12 Weeks
Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine
Time frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
Changes in bacterial Load
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 4 Nov 2022.
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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 E Serena, MD,FACS principal investigator
Serena Group, Inc
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual Layer Amniotic Membrane (DLAM). Artacent® in people with Chronic Diabetic Foot Ulcers, run by SerenaGroup, Inc. at 16 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Puerto Rico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas E Serena, MD,FACS (814-688-4000, serena@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
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 4 Nov 2022.