NCT01450943

Brief Summary

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 17, 2019

Completed
Last Updated

September 17, 2019

Status Verified

August 1, 2019

Enrollment Period

6.2 years

First QC Date

October 7, 2011

Results QC Date

July 31, 2019

Last Update Submit

August 26, 2019

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot UlcerChronic woundsChronic ulcersOasisDermagraftAdaptic

Outcome Measures

Primary Outcomes (1)

  • Wound Closure by Week 15

    The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.

    15 weeks

Secondary Outcomes (2)

  • Wound Closure at 20 Weeks

    20 weeks

  • Cost Effectiveness

    12 weeks

Study Arms (3)

Standard of care

ACTIVE COMPARATOR

debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape

Device: SECONDARY dressing gauze and tapeProcedure: debridement, irrigation

Dermagraft

EXPERIMENTAL

debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape

Device: SECONDARY dressing gauze and tapeProcedure: debridement, irrigationDevice: Dermagraft

Oasis

EXPERIMENTAL

debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape

Device: SECONDARY dressing gauze and tapeProcedure: debridement, irrigationDevice: Oasis

Interventions

SECONDARY dressing gauze and tapeDEVICE

SECONDARY dressing gauze and tape

DermagraftOasisStandard of care
debridement, irrigationPROCEDURE

debridement, irrigation

DermagraftOasisStandard of care
DermagraftDEVICE

Dermagraft per company protocol

Dermagraft
OasisDEVICE

Oasis per company protocol

Oasis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (Answering NO will exclude patient):
  • An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
  • The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
  • Subjects between 18 and 85 years of age.
  • Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.6.
  • The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.
  • Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
  • Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
  • Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
  • Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
  • For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
  • Subject understands the requirements of this study and is willing to comply with all the study requirements.

You may not qualify if:

  • (Answering YES will exclude patient):
  • The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
  • The subject is diagnosed with HIV/AIDS.
  • The subject is diagnosed with any bleeding disorders.
  • The subject is diagnosed with any connective tissue diseases.
  • For female subjects, the subject is pregnant or lactating.
  • The subject has a history of illicit drug use within one year of enrollment.
  • In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
  • The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
  • Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
  • The subject is diagnosed with active Charcot as described by Saunder's classification system.
  • The subject manifests signs of poor nutritional status and/or albumin level \< 2.9.
  • The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.
  • The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.
  • The subject has any porcine allergy or cow product allergy.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

Related Publications (1)

  • Lev-Tov H, Li CS, Dahle S, Isseroff RR. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial. Trials. 2013 Jan 9;14:8. doi: 10.1186/1745-6215-14-8.

    PMID: 23298410DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

DebridementTherapeutic Irrigation

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeHydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Results Point of Contact

Title
Sara Dahle, D.P.M., M.P.H.
Organization
VA Northern California Health Care System
Sara.dahle@va.gov
916-843-7151

Study Officials

  • Rivkah R. Isseroff, MD

    VA Northern California Health Care System, Mather, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 13, 2011

Study Start

October 1, 2011

Primary Completion

December 14, 2017

Study Completion

April 4, 2018

Last Updated

September 17, 2019

Results First Posted

September 17, 2019

Record last verified: 2019-08

Locations

US(1)