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Diabetic Foot UlcerPhase 4NCT01835379

Study of Oasis Ultra in Diabetic Foot Ulcers

A Phase 4 study testing Oasis and Standard in people with Diabetic Foot Ulcer, run by Healthpoint at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Oasis and Standard
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
16 sitesUnited States
Study dates
May 2013to Sep 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Study site

    Bayonne, New Jersey, 07002

  • Study site

    Carlsbad, California, 92009

  • Study site

    Dallas, Texas, 75224

  • Study site

    Dallas, Texas, 75243

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Fair Oaks, California, 95628

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fresno, California, 93720

  • Study site

    Houston, Texas, 77036

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    McAllen, Texas, 78501

  • Study site

    Saginaw, Michigan, 48602

  • Study site

    San Diego, California, 92103

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Virginia Beach, Virginia, 23464

Other trials in United States

About this study

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

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 .

Being tested
Oasis, Standard
Keywords
Diabetes, Diabetic Foot Ulcer, Diabetic Foot Wound, Non-healing foot wound, Oasis, Diabetic neuropathy
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OasisDevice

    Oasis Ultra will be applied once per week for up to 12 weeks.

  • StandardOther

    Also called Standard Care

Study groups in NCT01835379
Study groupRoleWhat they receive
OasisExperimentalOasis
Receives: Device: Oasis
StandardOtherStandard Care
Receives: Other: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Wounds Closed

    Measured: At the end of 12 Weeks

Secondary outcomes (1)

  1. Time to Wound Closure

    Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.

    Measured: During the 12 Week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835379
Sponsor's protocol ID
815-999-09-010
Status last verified
Jan 2015
First submitted
16 Apr 2013
Last updated
22 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oasis and Standard in people with Diabetic Foot Ulcer, run by Healthpoint at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Wounds Closed (time frame: At the end of 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01835379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.

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