Status:
UNKNOWN
Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers
Lead Sponsor:
Southern California Institute for Research and Education
Collaborating Sponsors:
Heritage Medical Research Institute
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 ...
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 necr...
Eligibility Criteria
Inclusion
- 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
- Wounds cannot be positioned more than 2.5cm proximal to the malleoli, but may involve any more distal position of the foot
- Type 2 Diabetic Mellitus Neuropathic ulcers present at least for 3months with failure to heal
- 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
- Ulcer(s) must be stage II or III full-thickness (extending through the subcutaneous tissue or beyond - Wagner grade II or III)
- No joint, tendon or bone exposure
- Located on the lower extremity.
- Ulcer size measures 1cm2 \< 16 cm2
- No osteomyelitis affecting the area of the ulcer
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00446472
Start Date
April 1 2007
End Date
September 1 2010
Last Update
June 4 2010
Active Locations (2)
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1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
2
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073