Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Southern California Institute for Research and Education.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heritage Medical Research Institute
Information provided by:
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00446472
First received: March 8, 2007
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.


Condition Intervention
Diabetic Foot Ulcers
Drug: Regranex®
Drug: Hydrogel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Windowed Casts With and Without Regranex® Gel for Healing

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Completely healed wounds [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Randomized to Regranex gel
Drug: Regranex®
Regranex gel will be used for a total of 16 weeks
Other Name: Becaplermin
Active Comparator: 2
Placebo hydrogel will be used for a total of 16 weeks
Drug: Hydrogel
Placebo hydrogel will be applied for 16 weeks

Detailed Description:

Management of diabetic leg or foot ulcers is based on certain principals: 1) effective off-loading of pressure on the wound via specialized shoes, cast braces, or casts, 2) removal of infected or necrotic tissue vial surgery or non-surgical methods, and 3) optimization of wound healing by interventions that promote wound repair such as nutritional support, provision of optimal moisture balance and growth factor therapy.

Application of casts or cast braces [below knee, removable boots with protective padding] to protect and immobilize the ankle and foot have been demonstrated to provide superior wound healing than less cumbersome types of shoe gear (1-3). The benefit of casting may be the result of more effective off-loading of pressure than can be achieved with other devices, but the inability of patients to remove their casts also appears to an important factor, as non-compliance with removable cast-braces has been shown to be a pervasive and significant issue (4,5). One critical concept in diabetic foot ulcer management is the relation between chronically and limb loss — for each year a wound persists, a patient has a 25% risk for major amputation due to complications from infection (6-8). Limb loss has a profound effect on Diabetics' quality of life and rate of lower limb loss among diabetics is four per 1,000 person years in comparison with three per 10,000 person years (9-10).

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must sign an informed consent
  • Have a history of compliance and reliability in following study required treatment regimen.
  • Have diabetic mellitus Type I or Type II and have a glycohemoglobin Alc less than l0
  • Presence of one or two ulcers in lower extremities

    1. Wounds cannot be positioned more than 2.5cm proximal to the malleoli, but may involve any more distal position of the foot
    2. Type 2 Diabetic Mellitus Neuropathic ulcers present at least for 3months with failure to heal
    3. Post-operation wounds in DM patients with wound present for minimum 4 weeks after surgery and wound surface area has failed to decrease more than 20% in 4 weeks
    4. Ulcer(s) must be stage II or III full-thickness (extending through the subcutaneous tissue or beyond - Wagner grade II or III)
    5. No joint, tendon or bone exposure
    6. Located on the lower extremity.
    7. Ulcer size measures 1cm2 < 16 cm2
    8. No osteomyelitis affecting the area of the ulcer
    9. If two wounds, both can be incorporated into one window when cast applied
  • Adequate foot arterial circulation evidenced by palpable ankle pulses or Doppler with ABI less than or equal to 0.8. If non-compressible, must have triphasic wave Doppler velocity waveforms or toe/brachial pressure greater than or equal to 0.6.

Exclusion criteria:

  • Female subjects who are within child bearing age range.
  • Previous sensitivity to Regranex® Gel.
  • Use of topical antibiotics, enzymatic debriders on the selected ulcer(s) within 30 days preceding randomization.
  • Osteomyelitis affecting the area of the selected ulcer(s)
  • Exposed bone, joint or tendon at ulcer site (Wagner III or higher)
  • Presence of more than two full-thickness ulcers on targeted lower extremity
  • Requirement for systemic antibiotics use within 7 days of study entry
  • Inability to tolerate cast
  • Presence of systemic or local cancer of any kind
  • Life expectancy less than 1 year
  • Subjects with end stage renal failure requiring chronic hemodialysis
  • Concomitant use of Pletal or other vasodilators
  • Ankle Brachial Index less or equal to 0.8 or toe pressure index less than 0.6
  • ESR>20
  • Demonstration of poor compliance including a chronic alcohol, psychiatric condition or drug abuse problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446472

Locations
United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Contact: Christine Ma Agas    562-826-8000 ext 2889    christine.ma@va.gov   
Principal Investigator: Ian Gordon, M.D., Ph.D.         
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Aksone Nouvong, D.P.M.    310-268-3193    aksone.nouvong@va.gov   
Principal Investigator: Aksone Nouvong, D.P.M.         
Sponsors and Collaborators
Southern California Institute for Research and Education
Heritage Medical Research Institute
Investigators
Principal Investigator: Ian Gordon, M.D., Ph.D. VA Long Beach Healthcare System
Principal Investigator: Aksone Nouvong, D.P.M. VA Greater Los Angeles Healthcare System
  More Information

Additional Information:
Publications:

Responsible Party: Ian Gordon, M.D., VA Long Beach Health Care System
ClinicalTrials.gov Identifier: NCT00446472     History of Changes
Other Study ID Numbers: #778
Study First Received: March 8, 2007
Last Updated: June 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
diabetes mellitus
diabetic neuropathies
peripheral vascular diseases

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Platelet-derived growth factor BB
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014