Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366132
Status:
UNKNOWN
Last Update Posted:
2006-08-18
First Post:
2006-08-17
Brief Title:
Safety Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
Sponsor:
Tissue Regeneration Technologies
Organization:
Tissue Regeneration Technologies
Study Overview
Official Title:
DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 plantarbottom aspect of the foot and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment
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 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 P950032S016 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 55 per 1000 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 P990086S003 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
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 P950032S016 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 55 per 1000 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 P990086S003 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None