Chronic Diabetic Foot UlcersPhase 2NCT00366132
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
A Phase 2 study testing Extracorporeal Shockwaves in people with Chronic Diabetic Foot Ulcers, run by Tissue Regeneration Technologies at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- Extracorporeal Shockwaves
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 28Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Akron General
Akron, Ohio, 44307
Dawn Sues, RN, 330-344-1122
David Kay, MD
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Matthew Wagener, BS, 409-747-5749
Saul Trevino, MD
- Recruiting
Podiatry Group of South Texas
San Antonio, Texas, 78229
Rebecca Reyes, 830-981-5150
Richard L Childers, DPM
- Recruiting
Calvary Hospital
The Bronx, New York, 10461
Linda Waltrous, 718-518-2149
Oscar Alvarez, Ph.D.,WCA
- Recruiting
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Rene Laughlin, RN, 202-444-7288
Christopher Attinger, MD
About this study
Official title: 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.
Read the 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, 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.
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- Extracorporeal Shockwaves
- Keywords
- Diabetic, Foot Ulcers, TRT, DermaGold, Shockwave, ESWT, Diabetes Mellitus
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal ShockwavesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Healing
Secondary outcomes (6)
o A comparison of the total number of subjects with a final status of "Healed" in the active versus control group
o Partial healing at 12 weeks post treatment ((size of wound compared to baseline));
o Results of quantitative wound cultures (Ulcers with a quantitative wound culture with a bacterial count greater than 105 per gram of tissue will be defined as an infected ulcer);
o The percentage of the wound that has healed
o The number of shock wave treatments performed
o Durability of wound closure (i.e., status of wound at one week following determination of "healed")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Tissue Regeneration Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366132
- Sponsor's protocol ID
- G050198
- Status last verified
- Aug 2006
- First submitted
- 17 Aug 2006
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00366132
- Acronym / sponsor ID
- G050198
- Conditions
- Chronic Diabetic Foot Ulcers
- Keywords
- Diabetic, Foot Ulcers, TRT, DermaGold, Shockwave, ESWT, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Tissue Regeneration TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 18 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwaves | Device | – |
Primary outcome
Time to Complete Wound Healing
6 secondary outcomes
o A comparison of the total number of subjects with a final status of "Healed" in the active versus control group
o Partial healing at 12 weeks post treatment ((size of wound compared to baseline));
o Results of quantitative wound cultures (Ulcers with a quantitative wound culture with a bacterial count greater than 105 per gram of tissue will be defined as an infected ulcer);
o The percentage of the wound that has healed
o The number of shock wave treatments performed
o Durability of wound closure (i.e., status of wound at one week following determination of "healed")
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracorporeal Shockwaves in people with Chronic Diabetic Foot Ulcers, run by Tissue Regeneration Technologies at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Wound Healing. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.