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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Evaluation of Windowed Casts With and Without Regranex® Gel for Healing

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Drug: Regranex®
* Drug: Hydrogel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Randomized to Regranex gel | Drug: Regranex®<br>* Regranex gel will be used for a total of 16 weeks<br>* Other names: Becaplermin;|
| Active Comparator: 2<br>Placebo hydrogel will be used for a total of 16 weeks | Drug: Hydrogel<br>* Placebo hydrogel will be applied for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completely healed wounds |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, diabetic neuropathies, peripheral vascular diseases