NCT01835379

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 22, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

April 16, 2013

Results QC Date

January 5, 2015

Last Update Submit

January 20, 2015

Conditions

Diabetic Foot Ulcer

Keywords

DiabetesDiabetic Foot UlcerDiabetic Foot WoundNon-healing foot woundOasisDiabetic neuropathy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Wounds Closed

    At the end of 12 Weeks

Secondary Outcomes (1)

  • Time to Wound Closure

    During the 12 Week treatment period

Study Arms (2)

Oasis

EXPERIMENTAL

Oasis

Device: Oasis

Standard

OTHER

Standard Care

Other: Standard

Interventions

OasisDEVICE

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

Oasis
StandardOTHER
Also known as: Standard Care
Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Carlsbad, California, 92009, United States

Location

Unknown Facility

Fair Oaks, California, 95628, United States

Location

Unknown Facility

Fresno, California, 93720, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Evansville, Indiana, 47713, United States

Location

Unknown Facility

Madisonville, Kentucky, 42431, United States

Location

Unknown Facility

Shreveport, Louisiana, 71101, United States

Location

Unknown Facility

Saginaw, Michigan, 48602, United States

Location

Unknown Facility

Bayonne, New Jersey, 07002, United States

Location

Unknown Facility

Dallas, Texas, 75224, United States

Location

Unknown Facility

Dallas, Texas, 75243, United States

Location

Unknown Facility

Fort Worth, Texas, 76104, United States

Location

Unknown Facility

Houston, Texas, 77036, United States

Location

Unknown Facility

McAllen, Texas, 78501, United States

Location

Unknown Facility

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusDiabetic Neuropathies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Vice President, Medical & Clinical Affairs
Organization
Smith & Nephew, Inc.
jaime.dickerson@smith-nephew.com
817-302-3914

Study Officials

  • Herbert B Slade, MD

    Healthpoint

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 18, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 22, 2015

Results First Posted

January 22, 2015

Record last verified: 2015-01

Locations

US(16)