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TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TheraGauze

Regranex

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Foot, Extremity, Ulcer, Wound, Gauze

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients

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.

Exclusion Criteria: Patients

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;
having sickle cell disease;
having exposed bone, tendon, or fascia;
who are currently enrolled in a clinical evaluation of another investigational device or drug, or have received and investigational treatment for diabetic foot ulcers in the last 30 days;
unable to comply with the procedures described in the protocol.

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

TheraGauze alone

Theragauze + Regranex

Outcomes

Primary Outcome Measures

Frequency of complete wound healing within 12 weeks

Time to complete wound healing within 12 weeks

Secondary Outcome Measures

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

Adverse events (infection, cellulites, seroma, etc.)

Excess pain

Full Information

NCT ID

NCT00389636

First Posted

October 18, 2006

Last Updated

May 5, 2008

Sponsor

Solsys Medical LLC

1. Study Identification

Unique Protocol Identification Number

NCT00389636

Brief Title

TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Official Title

TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

July 2008 (Anticipated)

Study Completion Date

July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Solsys Medical LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will evaluate the use of TheraGauzeT (Soluble Systems, LLC) wound dressing, a polymer hydrogel chemically impregnated into a rayon/polyester formed fabric, forming a pliable, conforming solid matrix. TheraGauze is FDA Class I exempt (regulation #21CFR, product code 5878.4022). It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers. It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function. This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Diabetes, Foot, Extremity, Ulcer, Wound, Gauze

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

TheraGauze alone

Arm Title

Arm Type

Active Comparator

Arm Description

Theragauze + Regranex

Intervention Type

Device

Intervention Name(s)

TheraGauze

Intervention Description

TheraGauze

Intervention Type

Drug

Intervention Name(s)

Regranex

Intervention Description

Regranex + TheraGauze

Primary Outcome Measure Information:

Title

Frequency of complete wound healing within 12 weeks

Title

Time to complete wound healing within 12 weeks

Secondary Outcome Measure Information:

Title

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

Title

Patient's assessment (pain, itching)

Title

Presence of epithelialization visible on the wound surface

Title

Occurrence of infection at the wound site

Title

Recurrence of ulcer during the 20 week follow-up period

Title

Adverse events (infection, cellulites, seroma, etc.)

Title

Excess pain

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 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. Exclusion Criteria: Patients 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; having sickle cell disease; having exposed bone, tendon, or fascia; who are currently enrolled in a clinical evaluation of another investigational device or drug, or have received and investigational treatment for diabetic foot ulcers in the last 30 days; unable to comply with the procedures described in the protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Laumann, MBChB, MRCP

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adam Landsman, DPM, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

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