AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

A Prospective, Multi-Center, Randomized, Parallel-group Study Comparing AMNIOEXCEL Plus Placental Allograft Membrane to a Marketed Comparator and Standard of Care Procedures in the Management of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547635
• Other study ID #: T-AEPDFU-001
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: July 2020
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Have participated in the informed consent process and signed a study-specific informed consent document.

2. Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.

3. Be = 21 years of age.

4. Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of = 12%.

5. Have at least one diabetic foot ulcer Ulcer size (i.e., area) is > 1 cm2 and < 12 cm2.

6. Have adequate vascular perfusion of the affected limb

Exclusion Criteria:

1. The subject was previously randomized and treated under this clinical study protocol.

2. The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.

3. The subject is unable to safely ambulate with the use of a study required offloading boot.

4. The subject has suspected or confirmed gangrene or wound infection of the study ulcer.

5. The subject has suspected or confirmed osteomyelitis.

6. In the opinion of the Investigator, the subject has received 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 wound healing

7. The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.

8. The subject is currently pregnant or is actively trying to conceive.

9. In the opinion of the Investigator, the subject is unable to comply with the treatment regimen

10. 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 wound healing.

11. In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.

12. The subject has ulcers secondary to a disease other than diabetes.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• AMNIOEXCEL Plus Amniotic Membrane
AMNIOEXCEL 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. This product is an allograft tissue intended for 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. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.

Device:
• A Marketed Comparator
bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

Other:
• Standard of Care
Coban™ Conforming gauze Optifoam® non-adhesive dressing Cotton Gauze Normal saline (liquid or gel) Non-adhering dressings Steristrips An offloading boot (Pneumatic Short Leg Walker), as appropriate

Locations

Country	Name	City	State
United States	California 1	Fresno	California
United States	California 3	Fresno	California
United States	Georgia 1	Gainesville	Georgia
United States	California 2	Los Angeles	California
United States	Texas 1	San Antonio	Texas
United States	Illinois 1	Springfield	Illinois
United States	New Jersey 1	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016 Oct 1;25(Sup10):S8-S17. doi: 10.12968/jowc.2016.25.Sup10.S8. — View Citation

Snyder RJ, Cardinal M, Dauphinée DM, Stavosky J. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Manage. 2010 Mar 1;56(3):44-50. — View Citation

Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.	Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.	Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported