UnknownNot Applicable

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

United States60 participantsStarted 2007-04

Plain-language 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 on the legs and feet.

Who can participate

Age range21 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Completely healed wounds

Timeframe: 4 months

Trial details

NCT IDNCT00446472

SponsorSouthern California Institute for Research and Education

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Diabetic Foot Ulcers trials