Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

NCT02880592 | Completed

• 1 other identifier: NT-DFU-AFF-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Time to initial closure of diabetic foot ulcer

  Time to initial closure of diabetic foot ulcers will be compared between the two groups.

  12 weeks

Secondary Outcomes (4)

• Proportion of healed wounds

  12 weeks

• Proportion of healed wounds

  4 weeks

• Quality of Life measurement

  baseline and 12 weeks

• Incidence of adverse events

  12 weeks

Study Arms (2)

Fresh amniotic membrane/standard of care

EXPERIMENTAL

This group will receive the Affinity Allograft and standard of care.

Other: Affinity Allograft; Other: Standard of care

Standard of Care

ACTIVE COMPARATOR

This group will receive standard of care for diabetic foot ulcers that includes offloading of the diabetic foot ulcer, debridement, and infection management using the appropriate dressings.

Other: Standard of care

Interventions

Affinity Allograft OTHER

fresh hypothermically stored human amniotic membrane

Fresh amniotic membrane/standard of care

Standard of care OTHER

offloading, debridement, infection management using appropriate dressings

Fresh amniotic membrane/standard of care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Presence of a diabetic foot ulcer, Wagner 1 or 2 grade , extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle, on any aspect of the foot provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if 2 or more DFUs are present with the same Wagner grade and will be the only one in the study. If other ulcerations are present on the same foot they have to be more than 2 cm apart from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
• Study ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first treatment visit.
• Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an ABI between 0.7 and 1.3 within 3 months of the first Screening Visit,or TBI of \> 6 within 3 months of the first Screening Visit .
• The target ulcer has been offloaded for at least 14 days prior to randomization.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.

You may not qualify if:

• Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10 mg daily), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
• History of radiation at the ulcer site.
• Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first Screening Visit or will need to be treated with any prohibited therapies.
• Affected extremity requiring negative pressure wound therapy or subject requiring hyperbaric oxygen during the course of the trial.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
• Osteomyelitis or bone infection of the affected foot as verified by X-ray within 30 days prior to Randomization.
• Subject is pregnant or breast feeding.
• Presence of diabetes with poor metabolic control as documented with an HgA1c \> 12.0 within last 90 days.
• Patients with end stage renal disease.
• Index ulcer has reduced in area by 20% or more after 14 days of standard of care from the first screening visit (S1) to the TV1/randomization visit.

Sponsors & Collaborators

• Organogenesis: lead
• SerenaGroup, Inc.: collaborator

Study Sites (8)

GF Professional Research

Miami Lakes, Florida, 33016, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Henry Ford Macomb Hospital

Clinton Township, Michigan, 48038, United States

Location

Summit Health Hospital

Chambersburg, Pennsylvania, 17201, United States

Location

The Foot and Ankle Wellness Center

Ford City, Pennsylvania, 16226, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katie Mowry, PhD

  NuTech Medical, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)