NCT00389636

Brief Summary

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

1.8 years

First QC Date

October 18, 2006

Last Update Submit

May 5, 2008

Conditions

Diabetic Foot Ulcer

Keywords

DiabetesFootExtremityUlcerWoundGauze

Outcome Measures

Primary Outcomes (2)

  • Frequency of complete wound healing within 12 weeks

  • Time to complete wound healing within 12 weeks

Secondary Outcomes (7)

  • Investigator's or clinician's assessment of wound quality (ulcer duration, baseline area, staging, presence of fibrin or granulation tissue)

  • Patient's assessment (pain, itching)

  • Presence of epithelialization visible on the wound surface

  • Occurrence of infection at the wound site

  • Recurrence of ulcer during the 20 week follow-up period

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

TheraGauze alone

Device: TheraGauze

2

ACTIVE COMPARATOR

Theragauze + Regranex

Drug: Regranex

Interventions

TheraGauzeDEVICE

TheraGauze

1
RegranexDRUG

Regranex + TheraGauze

2

Eligibility Criteria

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

You may qualify if:

  • who are 18 years old or older;
  • who are diagnosed as having insulin-dependent or non-insulin-dependent diabetes mellitus (5.5% \<HgBA1C\<12%);
  • who have foot ulcers extending through the epidermis and dermis but not with exposed tendon or bone;
  • who have a diagnosis of chronic diabetic ulcer;
  • who have a viable wound bed with granulation tissue as determined by bleeding following debridement;
  • who have an ulcer size which is at least 1 cm2 and no greater then 16cm2;
  • who have signed an informed consent form.
  • who have a wound that has been present for at least 4 weeks at the time of screening.

You may not qualify if:

  • having ulcers less than 1cm2 or greater than 16cm2 in size;
  • having severe arterial disease (ankle brachial index (ABI) less than 0.65);
  • having history of radiation therapy to the ulcer site;
  • who use corticosteroids \>10mg prednisone daily
  • who use any immune suppressive, or severely immunocompromised patients;
  • who have an ulcer that was of a non-diabetic pathophysiology;
  • having vasculitis, severe rheumatoid arthritis, or other collagen vascular disease;
  • having malnutrition (defined by albumin \<2.5 g/dL);
  • having a known allergy or hypersensitivity to the components of either TheraGauze or Regranex;
  • having erythema or purulence associated with a severe infection of the wound site;
  • having signs and symptoms of cellulitis, osteomyelitis, necrotic or avascular ulcer beds;
  • undergoing hemodialysis;
  • having uncontrolled diabetes (defined as HgB A1c\>12%)
  • having deficient blood supply to ulcers (defined as capillary fill time \>3 seconds at tips of toes)
  • having Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusUlcerWounds and Injuries

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sisPlatelet-Derived Growth FactorIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsDNA-Binding ProteinsProteinsBiological Factors

Study Officials

  • Anne Laumann, MBChB, MRCP

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Adam Landsman, DPM, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

US(1)