Study of Oasis Ultra in Diabetic Foot Ulcers

A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers

Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Oasis; Other: Standard

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • California
    • Carlsbad, California, United States, 92009
    • Fair Oaks, California, United States, 95628
    • Fresno, California, United States, 93720
    • San Diego, California, United States, 92103
  • Indiana
    • Evansville, Indiana, United States, 47713
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
  • Michigan
    • Saginaw, Michigan, United States, 48602
  • New Jersey
    • Bayonne, New Jersey, United States, 07002
  • Texas
    • Dallas, Texas, United States, 75224
    • Dallas, Texas, United States, 75243
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77036
    • McAllen, Texas, United States, 78501
  • Virginia
    • Virginia Beach, Virginia, United States, 23464

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
• Subjects 18 years of age or older of either sex with a history of diabetes mellitus (Type 1 or 2) requiring medication (insulin and/or oral/injectable) to control blood glucose levels.
• A non-healing, Wagner grade 1 or 2, neuropathic diabetic foot ulcer.
• Willing and able to make all required study visits.
• Able to follow instructions.
• An ulcer present on any part of the plantar surface of the foot, which is 0.5 cm2 to 10 cm2 (inclusive), as measured at the Screening Visit prior to debridement, with a duration ≥ 6 weeks (documented in the patient's history or by patient report of onset) but not more than 12 months.
• Separation of at least 5 cm (wound edge to wound edge) if ≥ 2 wounds are present.
• Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of > 40 mmHg OR a transcutaneous oxygen pressure (TcPO2) ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable in lieu of ABI, but if both are obtained, each must meet its respective cutoff.

Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable (test result must be included in the source document).

• Target ulcer is not infected based on clinical assessment.
• Able to perform any required dressing changes at home or have a caregiver who can perform the dressing changes.
• Willing to use an appropriate off-loading device to keep weight off of foot ulcers.

• Blood counts and blood chemistry values as follows:

  • Alanine aminotransferase (ALT) ≤ 3x upper limit of normal
  • Aspartate aminotransferase (AST) ≤ 3x upper limit of normal
  • Serum albumin ≥ 2.0 g/dL •Pre-albumin levels of ≥ 10 mg/dL
  • Alkaline phosphatase ≤ 500 U/L •Serum total bilirubin ≤ 3.0 mg/dL
  • Serum BUN < 75 mg/dL •Serum creatinine ≤ 4.5 mg/dL
  • HbA1c ≤ 12% •Hemoglobin (Hgb) > 8.0 g/dL
  • WBC > 2.0 x 109/L •Absolute neutrophil count > 1.0 x 109/L
  • Platelet count > 50 x 109/L

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the study device or its components (e.g., porcine sensitivity).
• Participation in another investigational study within thirty (30) days of Visit 1 or planned participation overlapping with this study.
• Subjects with evidence of gangrene on either lower limb.
• Ulcers that require negative pressure or hyperbaric oxygen therapy.
• The Medical Monitor may declare any subject ineligible for a valid medical reason.
• Current treatment with disallowed medications or therapies. Subjects may not be enrolled into the study while using systemic antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oasis	Device: Oasis; Oasis Ultra will be applied once per week for up to 12 weeks.
Other: Standard; Standard Care	Other: Standard; Other Names: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Wounds Closed	At the end of 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Wound Closure	Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.	During the 12 Week treatment period

Collaborators and Investigators

• Sponsor: Healthpoint

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Estimate): January 22, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes; Diabetic neuropathy; Diabetic Foot Ulcer; Diabetic Foot Wound; Non-healing foot wound; Oasis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 815-999-09-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No