Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00235196
NCT00235196CompletedPhase 4

A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

Ethicon, Inc.3 sites in 1 country48 target enrollmentStarted: July 1, 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
48
Locations
3
Primary Endpoint
Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 years of age or older.
  • •Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
  • •Diagnosed Type 2 diabetic (i.e. not juvenile onset).
  • •Have a DFU on the plantar surface of either foot.
  • •Have a DFU of >4 wks but <6 months duration.
  • •Willing and capable of cooperating to the extent and degree required by the study protocol

Exclusion Criteria

  • •Be < 1cm2 or >10cm2 in area, by planimetry.
  • •Demonstrate overt signs of infection.
  • •Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
  • •Have visible exposed bone or tendon.
  • •Have an adjacent thermal injury or wound of an etiology other than diabetes.
  • •Be within 5 cm of any other wound, regardless of etiology.
  • •Have received enzymatic debriding agents in the past 7 days.
  • •Have received topical antibiotic therapy in the past 7 days.
  • •Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
  • •Have exposed bone or tendon, after debridement
  • •The study subject MUST NOT:
  • •Have received previous treatment for the study ulcer by this Investigator.
  • •Have more than 3 full thickness ulcers, in total.
  • •Be pregnant or nursing an infant
  • •Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
  • •Be a known alcohol or drug abuser.
  • •Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
  • •Have received radiotherapy, which includes the lower extremity, at any time.
  • •Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
  • •Have received an investigational drug or device in the past 30 days.
  • •Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
  • •Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
  • •Known to be non-compliant or unlikely to complete the study.
  • •Have ABPI < 0.7, OR, if ABPI >1.0 and toe pressure >0.
  • •Have serum Creatinine > 3 mg/dL
  • •have Hgb A1C>9%

Outcomes

Primary Outcomes

Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.

Secondary Outcomes

  • Rate of wound closure
  • Ease of use and adverse events
  • Wound odor
  • Quality of life
  • Wound characteristics

Investigators

Sponsor Class
Industry

Study Sites (3)

Loading locations...

Similar Trials

Completed
Phase 4
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg UlcersLeg Ulcer
NCT00235209Ethicon, Inc.48
Recruiting
Not Applicable
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOnType B Aortic Dissection
NCT06675617Intressa Vascular SA72
Unknown
Phase 4
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid DiverticulitisDiverticulitis, ColonicAcute Disease
NCT00097734Klinikum Hanover-Siloah Hospital540
Recruiting
Phase 3
Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNAHBVB-cell Lymphoma
NCT04539119Ruijin Hospital120
Completed
Phase 3
Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum ChemotherapyRelapsed Ovarian CancerPlatinum SensitiveFollowing Complete or Partial Response to Platinum Based Chemotherapy
NCT03534453AstraZeneca229