Status:
UNKNOWN
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
Lead Sponsor:
Tissue Regeneration Technologies
Conditions:
Chronic Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of ...
Detailed Description
Diabetic foot complications are the most common cause of nontraumatic lower extremity amputations in the industrialized world. The risk of lower extremity amputation ranges from 15 to 46 times higher ...
Eligibility Criteria
Inclusion
- Diagnosis of a single chronic plantar foot ulcer that has persisted for a minimum of 6 weeks duration
- History of Type 2 diabetes mellitus; (track/ask if insulin dependent)
- Capable of wound care at home;
- The ulcer measures \> 1 cm and \<4 cm at any dimension
- The ulcer is Stage 1 or 2A according to the classification system described by Lavery et al.
- Stage 1 - superficial wounds through the epidemis or epidermis and dermis that did not penetrate to tendon, capsule or bone.
- Stage 2A - Clean wounds that penetrated to tendon or capsule.
- Palpable pedal pulse in the affected leg OR peripheral vascular disease evaluation demonstrating acceptable blood supply to affected foot;
- Subjects age \> 18 years;
- The Investigator has completed a medical history and a physical examination to assure that the subject meets all study enrollment criteria;
- The subject is willing and able to read, understand and sign the study specific informed consent form; and
- The subject agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the wound (e.g., wet to wet dressings, orthotics) and all follow up visit requirements.
Exclusion
- Pregnancy
- Type I diabetes
- Plantar foot ulcer extends to and /or involves the bone or joint;
- Ulcers are present on both feet
- Multiple ulcers on the foot
- Clinical evidence of cellulitis at the ulcer site or surrounding area;
- Ulcers that have purulent exudates or malodorous exudates on visual examination
- Diagnosis of a chronic plantar foot ulcer that has persisted for \>1 year.
- Peripheral vascular disease per the study enrollment work-up requiring vascular surgery intervention.
- ABI (Ankle Brachial Index) \< 0.6 Ulcer debridement under anesthesia in OR required within the 2 week observation phase,
- Lower extremity revascularization procedure (e.g. PTA, graft, etc.) within eight (8) weeks of the study screening visit.
- Uncorrected biomechanical abnormalities that cause or contribute to the affected lower extremity ulcer; (e.g. tight Achilles tendon, hammer toe, Charcot foot etc.)
- Surgical procedure to correct biomechanical abnormities (e.g., lengthening of the Achilles tendon. correction of hammer toe, Charcot foot correction) within eight (8) weeks of the study screening visit;
- Deep vein thrombosis within 6 months of study screening visit;
- Clinical evidence of lymphadema;
- Active or previous (within 60 days prior to the study screening visit) chemotherapy;
- Treatment of the plantar foot ulcer with growth factors, prostaglandin therapy or vasodilator therapy during the 2 week observation phase.
- Subject on steroid therapy
- Sickle cell anemia
- Infection with Human Immunodeficiency Virus
- Immunodeficiency disorders
- Severe protein malnutrition - serum albumin \< 2.0g/dl
- Severe anemia - Hgb \< 7 g/dl (males) or \< 6.5 (females)
- Recent treatment (within 60 days prior to the study screening visit) with immunosuppresants, radiation, or biologically active cellular / acellular products;
- Current history of substance abuse.
- Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits;
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; or
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00366132
Start Date
March 1 2006
Last Update
August 18 2006
Active Locations (5)
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1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
Calvary Hospital
The Bronx, New York, United States, 10461
3
Akron General
Akron, Ohio, United States, 44307
4
University of Texas Medical Branch
Galveston, Texas, United States, 77555