NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

NCT02461641 | Completed

• 1 other identifier: RD2014-08-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 7

Brief Summary

This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.

Conditions

Foot Ulcer, Diabetic

Keywords

amniotic tissue; diabetic foot ulcer; Affinity; NuShield

Outcome Measures

Primary Outcomes (1)

• Mean adjusted heal rate

  Percentage change in area method using ARANZ camera

  4 weeks

Secondary Outcomes (2)

• Extent of wound closure at 12 weeks

  12 weeks

• Length of time to 100% healing of foot ulcer

  Up to 12 weeks

Study Arms (3)

Standard of Care

OTHER

Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe.

Other: Standard of Care

NuShield

EXPERIMENTAL

Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a dehydrated amnion-chorion membrane, NuShield, for up to 4 weeks.

Other: NuShield

Affinity

EXPERIMENTAL

Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a fresh hypothermically stored amniotic membrane, Affinity, for up to 4 weeks.

Other: Affinity

Interventions

NuShield OTHER

NuShield is a sterilized dehydrated amnion chorion membrane patch.

NuShield

Affinity OTHER

Affinity is a aseptically produced hypothermically stored amniotic membrane patch.

Affinity

Standard of Care OTHER

Standard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe.

Standard of Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is or greater than 18 years old.
• Type 1 or Type 2 diabetes.
• Subject has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care.
• Subject's ulcer size \>0.5cm2 and \< 20cm2 area post-debridement.
• Subject has well controlled glucose levels, with HbA1c \< 10%.
• Subject has adequate lower extremity perfusion, with Ankle-Brachial Index \> 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) \> 30 mmHg. Presence of tibial and plantar pulses is preferred.
• Subject should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis).
• Subject should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc.
• Subject should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc

You may not qualify if:

• Patients with evidence of skin cancer within or adjacent to the ulcer site.
• Patients who have signs and symptoms of boney pathology (i.e. osteomyelitis) following debridement.
• Patients with ulcers on the calcaneus.
• Patients who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index \< 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) \< 30 mmHg; absence of tibial or plantar pulses.
• Patients who have documented clinically significant medical conditions, which would impair wound healing. This includes:
• Renal impairment (creatinine \>2.5 mg/dL);
• Hepatic impairment (2XULN);
• Hematological disorders (abnormities of formed elements);
• Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
• Patients with signs and symptoms of cellulitis;
• Patients with ulcers with sinus tracts associated with an ongoing infection;
• Patients with active deep vein thrombosis;
• Patients with uncontrolled diabetes, as demonstrated by increased HbA1C (\> 10%);
• Immunocompromised patients (e.g., lymphoma, AIDS, myelodysplastic disorders)
• Patients with a history of basal cell carcinomas or actinically induced squamous cell carcinomas which have been effectively treated are not excluded, except if the skin cancer was in the exact location of the target ulcer.

Sponsors & Collaborators

• NuTech Medical, Inc: lead
• Organogenesis: collaborator

Study Sites (7)

Limb Preservation Platform

Fresno, California, 93720, United States

Location

The Miller Care Group

Indianapolis, Indiana, 46234, United States

Location

The Wound Treatment Center

Opelousas, Louisiana, 70570, United States

Location

Wound Institute and Research Center

Dunmore, Pennsylvania, 18512, United States

Location

Temple University School of Pediatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Richard C. Galperin, DPM, FAPWCA

Dallas, Texas, 75224, United States

Location

Futuro clinical Trials, LLC

McAllen, Texas, 78501, 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, a division of Organogenesis

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: March 1, 2015
• Primary Completion: April 30, 2018
• Study Completion: October 25, 2018
• Last Updated: February 22, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)