Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
Recruitment status was Recruiting
|First Received Date ICMJE||August 17, 2006|
|Last Updated Date||August 17, 2006|
|Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Time to Complete Wound Healing|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers|
|Official Title ICMJE||DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus|
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 a chronic plantar foot ulcer in subjects with diabetes mellitus. For the purpose of this study, the definition of plantar foot ulcer is a wound or open sore that involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment.
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 in diabetics than in persons who do not have diabetes mellitus. Furthermore, foot complications are the most frequent reason for hospitalization in patients with diabetes, accounting for up to 25 percent of all diabetic admissions in the United States and Great Britain. The vast majority of diabetic foot complications resulting in amputation begin with the formation of skin ulcers. Early detection and appropriate treatment of these ulcers may prevent up to 85 percent of amputations. (Armstrong)
The primary goal in the treatment of diabetic foot ulcers is to obtain wound closure. Rest, elevation of the affected foot, and relief of pressure are basic treatments that are usually initiated when the patient first presents with a foot ulcer. A postoperative shoe or another type of pressure-relieving footwear is also often prescribed. Crutches or a wheelchair might also be recommended to totally off-load pressure from the foot. Necrotic tissue is debrided to allow full visualization of the extent of the ulcer, to allow detect underlying abscesses or sinuses, and to support healing. Wet-to-wet dressings are used to provide a warm, moist environment that is protected from external contamination is most conducive to wound healing. Additional options include numerous topical medications and gels, and special dressings, including semipermeable films, foams, hydrocolloids, and calcium alginate swabs.
When these more conservative treatments fail, another recently developed nonoperative option is available. The genetically engineered platelet-derived growth factor becaplermin (Regranex Gel, OMJ Pharmaceuticals, Inc.) is approved for use on neuropathic diabetic foot ulcers and can expedite healing. Growth factors stimulate chemotaxis and mitogenesis of neutrophils, fibroblasts, and monocytes, as well as other components that form the cellular basis of wound healing.
When nonoperative treatments fail, skin grafting is often required to achieve wound closure. In addition to autologous donor tissue for the graft procedure, bioengineered skin (Apligraf, Organogenesis, P950032/S016) and human dermis (Dermagraft, Smith & Nephew, P000036) are new types of biologically active implants approved for diabetic foot ulcers that are derived from fibroblasts of neonatal foreskins. These bioengineered products enhance healing by acting as delivery systems for growth factors and extracellular matrix components through the activity of live human fibroblasts contained in their dermal elements. (Frykberg)
Despite the variety of modalities available to treat diabetic foot ulcers, the US Center for Disease Control reports that the age-adjusted lower extremity amputation rate for persons with diabetes is 5.5 per 1,000 persons with diabetes, which is was 28 times that of persons without diabetes.
ESWT for Soft Tissue Indications
The use of extracorporeal shock waves for clinical applications was introduced in the United States more than 20 years ago; the first indication for use approved by FDA was for treatment of renal calculi (kideny stones). Since that time, the clinical applications of extracorporeal shock wave therapy (ESWT) have been expanded to include treatment of chronic proximal plantar fasciitis (P990086, HealthTronics OssaTron; P000048, Dornier EPOS Ultra; P040026, Orthospec Extracorporeal Shock Wave Device; P040039, Orthometrix Orbasone Pain Relief System) and chronic lateral epicondylitis (P990086/S003, HealthTronics OssaTron; P010039, Siemens Sonocur Basic). In addition, there are numerous reports in the clinical and pre-clinical literature of shockwave therapy used to treat orthopedic conditions such as fracture non-unions, femoral head necrosis, and non-orthopedic conditions related to tissue healing.
Treatment with extracorporeal shock waves has been shown to be associated with neovascularization in an animal model. Further, since several shockwave systems have been approved through the PMA process for treatment of chronic proximal plantar fasciitis and chronic lateral epicondylitis, there is a large amount of data regarding the safety of these devices in treating soft tissue. The research done by Meirer et al. (2005) and by Nishida et al. (2004) suggests that local delivery of shockwave therapy results in increased release of growth factors and improved circulation in the wound.
Because of the promising association between ESWT and tissue healing, the favorable risk / benefit profile of the devices approved for treatment of soft tissue indications, and the European clinical experience with ESWT for wound healing, it is hypothesized that extracorporeal shock wave treatment (ESWT) could be beneficial in treating diabetic foot ulcers. Therefore, this IDE describes a clinical study designed to determine the safety and effectiveness of the DermaGold® ESW System when used to induce healing of chronic plantar foot ulcers in patients with diabetic foot ulcers.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Chronic Diabetic Foot Ulcers|
|Intervention ICMJE||Device: Extracorporeal Shockwaves|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00366132|
|Other Study ID Numbers ICMJE||G050198|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Tissue Regeneration Technologies|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Tissue Regeneration Technologies|
|Verification Date||August 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP