Study of Oasis Ultra in Diabetic Foot Ulcers

Study Description

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Brief Summary:

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 .

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Device: Oasis; Other: Standard	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	82 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers
Study Start Date :	May 2013
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Wounds Closed [ Time Frame: At the end of 12 Weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Carlsbad, California, United States, 92009
Fair Oaks, California, United States, 95628
Fresno, California, United States, 93720
San Diego, California, United States, 92103
United States, Indiana
Evansville, Indiana, United States, 47713
United States, Kentucky
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Shreveport, Louisiana, United States, 71101
United States, Michigan
Saginaw, Michigan, United States, 48602
United States, New Jersey
Bayonne, New Jersey, United States, 07002
United States, 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
United States, Virginia
Virginia Beach, Virginia, United States, 23464

Sponsors and Collaborators

Healthpoint

Investigators

Study Chair:	Herbert B Slade, MD	Healthpoint

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Healthpoint
ClinicalTrials.gov Identifier:	NCT01835379 History of Changes
Other Study ID Numbers:	815-999-09-010
First Posted:	April 18, 2013
Results First Posted:	January 22, 2015
Last Update Posted:	January 22, 2015
Last Verified:	January 2015

Keywords provided by Healthpoint:

Diabetes; Diabetic Foot Ulcer; Diabetic Foot Wound	Non-healing foot wound; Oasis; Diabetic neuropathy

Additional relevant MeSH terms:

Ulcer; Diabetic Foot; Foot Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer	Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases