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Diabetic Foot UlcerNCT05024656

AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers

A study testing AmnioExcel Plus Amniotic Membrane in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of 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
What is being tested?
AmnioExcel Plus Amniotic Membrane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2021to Jun 2024
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

  • Have participated in the informed consent process and signed a study-specific informed consent document
  • Be willing to comply with study procedures, including study visits, and compliance with study required off-loading/protective device for the duration of the study
  • Be at least 18 years of age
  • If female and of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable
  • Have Type II or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of less than or equal to 12% within 3 months prior to Screening Visit
  • Have at least one diabetic foot ulcer that meets ALL the following criteria:
Show all 19Show fewer
  • Ulcer which has been in existence for a minimum of four weeks, prior to signing the Informed Consent Form allowing trial participation
  • Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure
  • Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone
  • Ulcer is located on the foot or ankle (with no portion above the top of the malleolus)
  • Ulcer size (area) is greater than equal to 1 cm2 and less than equal to 12 cm2 post-debridement
  • Have a minimum 4cm margin between the qualifying study ulcer and any other ulcer on that same foot, post-debridement
  • If the subject has more than one ulcer that meets eligibility criteria, the ulcer designated as the study ulcer will be at the discretion of the investigator
  • Have adequate vascular perfusion of the affected limb as defined by at least one of the following within the past 60 days:
  • Ankle-Brachial Index (ABI) greater than equal to 0.7 and less than equal to 1.2, performed within 60 days of screening,
  • Toe pressure (plethysmography) > 40 mmHg at time of screening, or
  • TcPO2 > 50 mmHg at time of screening
  • Be willing and able to maintain required applicable dressing changes as well as study required off-loading/protective device for the duration of the study
  • Have a study wound severity Wagner I or II

Who cannot join

  • Previously randomized and treated under this clinical study protocol
  • Patients with a known history of poor compliance with medical treatments
  • Suspected or confirmed gangrene or ulcer infection of the study ulcer or is receiving systemic/IV antibiotics at the time of randomization
  • Suspected or confirmed osteomyelitis of the foot with the study ulcer
  • Participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization
  • Received within 28 days of signing Informed Consent Form, or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis)
Show all 12Show fewer
  • History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy (i.e., systemic steroids, anti-rheumatics, TNF inhibitors, active chemotherapy, immunosuppressive therapy, autoimmune disease therapy) within 12 months prior to signing Informed Consent Form allowing trial participation
  • In the opinion of the investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia)
  • In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing
  • Have ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders)
  • In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing
  • Study Ulcer has received ulcer dressings that included growth factors, engineered tissues, or skin substitutes within 28 days of randomization, or is scheduled to receive such treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix, Grafix, GraftJacket, OASIS, Omnigraft, or Integra BMWD)

About this study

Official title: A Prospective, Multi-Center, Randomized Controlled, Parallel Group, Trial Evaluating the Use of AmnioExcel Plus Placental Allograft Membrane for the Management of Diabetic Foot Ulcers

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).

Read the detailed description

This study will have three (3) phases: (1) a Screening Phase, (2) a Treatment Phase, and (3) a Follow-up Phase. Subjects will be seen weekly in the Screening and Treatment Phases.

Subjects will be seen weekly in the Screening and Treatment Phases. Subjects who achieve confirmed wound closure during the Treatment Phase will be entered into the Follow-up Phase and will return to the site four (4) weeks following that confirmation visit.

Being tested
AmnioExcel Plus Amniotic Membrane, Standard of Care
Keywords
diabetic foot, diabetes mellitus, diabetes complications
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Diabetes Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmnioExcel Plus Amniotic MembraneOther

    AmnioExcel® Plus will be applied weekly, in conjunction with SOC, if the ulcer remains open, or up to and including Week 11, whichever comes first.

  • Standard of CareOther

    The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.

Study groups in NCT05024656
Study groupRoleWhat they receive
AmnioExcel Plus Amniotic Membrane + Standard of CareExperimentalAmnioExcel Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering in the homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AmnioExcel Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. Standard of care includes the following: * Coban™ * Conforming gauze * Optifoam® non-adhesive dressing * Xtrasorb® for highly exudated wounds * Cotton Gauze * Normal saline (liquid or gel) * Non-adhering dressings * Steristrips * Offloading boot, as appropriate
Receives: Other: AmnioExcel Plus Amniotic Membrane; Other: Standard of Care
Standard of CareActive comparator* Coban™ * Conforming gauze * Optifoam® non-adhesive dressing * Xtrasorb® for highly exudated wounds * Cotton Gauze * Normal saline (liquid or gel) * Steristrips * Offloading boot, as appropriate
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of complete wound closure

    Number of wounds with complete wound closure as assessed by the investigator. Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.

    Measured: Up to 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Why it stopped: Sponsor decision

Resources

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
This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024656
Sponsor's protocol ID
T-AEPDFU-002
Status last verified
Oct 2021
First submitted
23 Aug 2021
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AmnioExcel Plus Amniotic Membrane in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation.

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 19 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of complete wound closure (time frame: Up to 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05024656.

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 2 Nov 2021.

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