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Trial registered on ANZCTR


Registration number
ACTRN12612001124820
Ethics application status
Approved
Date submitted
18/10/2012
Date registered
22/10/2012
Date last updated
22/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical Platelet Derived Growth Factor (PDGF) Versus Placebo Therapy of Diabetic Foot Ulcers Off-Loaded with Windowed Casts
Scientific title
Topical Platelet Derived Growth Factor (PDGF) Regranex Shows Equivalent Rate of Healing to Placebo for Diabetic Foot Ulcers Off-loaded with Windowed Casts
Secondary ID [1] 281409 0
Nil
Universal Trial Number (UTN)
U1111-1135-9766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 287656 0
Condition category
Condition code
Surgery 287994 287994 0 0
Other surgery
Metabolic and Endocrine 287999 287999 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients had the affected leg treated with a short leg walking cast windowed over the ulcer. The cast consists of five layers: a thick hydrocolloid protective layer applied directly to the skin around the wound; then a layer of cotton gauze; then water resistant foam padding; then cotton padding; then fiberglass. A window is then cut with a cast saw over a pre-marked area of the cast that is over the ulcer. The cast application process takes approximately one hour. This was continued for 4 months with evaluation every two weeks. The PDGF gel was applied daily to the ulcer approximately 2 mm thick after cleaning the ulcer with saline. A bandage was applied over the gel and the window in the cast was then replaced and taped in place.
Intervention code [1] 285899 0
Treatment: Drugs
Intervention code [2] 285904 0
Treatment: Surgery
Comparator / control treatment
The placebo gel is identical in appearance and consistency to the Regranex gel except without PDGF. All patients had windowed casts.
Control group
Placebo

Outcomes
Primary outcome [1] 288202 0
The primary outcome is ulcer healing rate at four months. Clinical assessments were scheduled every two weeks from randomization until 4 months of treatment were complete. The assessments consisted of removal of the cast window for wound inspection. Healing was defined as complete epithelialization of the wound.
Timepoint [1] 288202 0
Every two weeks from randomization until four months of treatment were complete.
Secondary outcome [1] 299596 0
The patients with unhealed ulcers at 4 months were followed until wound healing or amputation. These final results for ulcer healing are included in the data and thus can be considered a secondary outcome. At nine months after randomization all patients had either healed, dropped out of the study or had an amputation of the affected limb.
Timepoint [1] 299596 0
nine months

Eligibility
Key inclusion criteria
Wagner Grade 1 Diabetic Foot Ulcer, ulcer area between 1-16 square centimerters
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Wagner Grade 2 ulcer or above, osteomyelitis or infection requiring antibiotics, ulcer area outside of range 1-16 square centimeters, more then two full thickness wounds on the involved extremity, moderate to severe peripheral arterial disease (ABI < 0.7), concomitant use of Pletal (cilostazol), inability to tolerate casting or unsteady gait, active neoplasia, concomitant steroid use, chronic alcohol or drug abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were screened in a surgical wound clinic for inclusion and exclusion criteria. Treatment allocation to placebo or PDGF was randomized on a 1:1 basis as follows. An equal number of pieces of paper labelled with placebo or Regranex were placed in a bag and at the time of randomization a secretary not involved in patient treatment or outcome assessment drew a piece of paper from the bag. The secretary then assigend the patient to the corresponding group and procured the study or placebo medication in a container that prevented identification of its contents. Thus both the patient and the treating physicians were blinded to which treatment group was selected. The physicians assessing outcomes were also blinded, as only the secretary had access to the randomization information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
See above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4608 0
United States of America
State/province [1] 4608 0
CA

Funding & Sponsors
Funding source category [1] 286170 0
Commercial sector/Industry
Name [1] 286170 0
Heritage Provider Network, Inc
Address [1] 286170 0
8510 Balboa Boulevard Suite 285
Northridge, CA 91325
Country [1] 286170 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Heritage Provider Network, Inc
Address
8510 Balboa Boulevard Suite 285
Northridge, CA 91325
Country
United States of America
Secondary sponsor category [1] 284981 0
Hospital
Name [1] 284981 0
Veterans Affairs Long Beach Healthcare System
Address [1] 284981 0
5901 East 7th Street
Long Beach, CA 90822
Country [1] 284981 0
United States of America
Other collaborator category [1] 277132 0
Hospital
Name [1] 277132 0
Veterans Affairs Greater Los Angeles Healthcare System
Address [1] 277132 0
11301 Wilshire Blvd.
Los Angeles, CA 90073
Country [1] 277132 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288236 0
Institutional Review Board at Veterans Affairs Long Beach Healthcare System
Ethics committee address [1] 288236 0
5901 East 7th St
Long Beach, CA 90822
Ethics committee country [1] 288236 0
United States of America
Date submitted for ethics approval [1] 288236 0
11/12/2006
Approval date [1] 288236 0
05/04/2007
Ethics approval number [1] 288236 0
00778

Summary
Brief summary
The was a multi-centered, randomized, controlled study to evaluate the efficacy of topical platelet derived growth factor (PDGF) in the treatment of diabetic foot ulcers. Forty six male patients with Wagner Grade 1 diabetic foot ulcers were randomized to treatment with PDGF hydrogel (tradename Regranex) versus placebo hydrogel, and all patients received treatment with a windowed cast for ulcer off-loading. Patients with abscess, osteomyelitis or infection requiring antibiotics were excluded. The patients were evaluated at four months after randomization for wound healing. Fifty two percent of the patients treated with PDGF plus windowed casts healed at four months compared to 57% of the placebo patients, yielding a non-significant p-value 0.79. Regranex gel does not appear to improve ulcer healing when combined with effective off-loading. Windowed casting is a safe and effective means of treating diabetic foot ulcers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34846 0
Address 34846 0
Country 34846 0
Phone 34846 0
Fax 34846 0
Email 34846 0
Contact person for public queries
Name 18093 0
Ian L Gordon, M.d., Ph.D.
Address 18093 0
Veterans Affairs Long Beach Healthcare System
Department of Surgery
Building 8, Room 324
5901 East 7th Street
Long Beach, CA 90822
Country 18093 0
United States of America
Phone 18093 0
1-562-826-8000 extension 5957
Fax 18093 0
1-562-826-5666
Email 18093 0
ian.gordon@va.gov
Contact person for scientific queries
Name 9021 0
Ian L Gordon, M.d., Ph.D.
Address 9021 0
Veterans Affairs Long Beach Healthcare System
Department of Surgery
Building 8, Room 324
5901 East 7th Street
Long Beach, CA 90822
Country 9021 0
United States of America
Phone 9021 0
1-562-826-8000 extension 5957
Fax 9021 0
1-562-826-5666
Email 9021 0
ian.gordon@va.gov

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary