Study of Oasis Ultra in Diabetic Foot Ulcers
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| ClinicalTrials.gov Identifier: NCT01835379 |
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Recruitment Status :
Completed
First Posted : April 18, 2013
Results First Posted : January 22, 2015
Last Update Posted : January 22, 2015
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Sponsor:
Healthpoint
Information provided by (Responsible Party):
Healthpoint
- Study Details
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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 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Oasis
Oasis
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Device: Oasis
Oasis Ultra will be applied once per week for up to 12 weeks. |
|
Standard
Standard Care
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Other: Standard
Other Name: Standard Care |
Primary Outcome Measures :
- Percentage of Wounds Closed [ Time Frame: At the end of 12 Weeks ]
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835379
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 |
| Responsible Party: | Healthpoint |
| ClinicalTrials.gov Identifier: | NCT01835379 History of Changes |
| Other Study ID Numbers: |
815-999-09-010 |
| First Posted: | April 18, 2013 Key Record Dates |
| 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:
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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 |