None listed
Conditions
Brief summary
Extracorporeal shockwave therapy (ESWT) is a new technology in the care of chronic non-healing wounds. The technology delivers high-energy pressure waves into the wound thereby enriching the ulcer with adequate blood through formation of new blood vessels. It also inhibits infection with its antibacterial property. Furthermore, it stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound. Recently, ESWT was reported to be effective in the initiation and acceleration of wound healing in various clinical settings including longstanding diabetic foot ulcers. The effectiveness of ESWT in wound healing, especially in treatment of diabetic foot ulcers has been demonstrated in numerous trials (1-2). It has been shown to be more effective value for money compared to hyperbaric oxygen therapy in management of chronic diabetic wounds (3). There are evidences demonstrating reduced length of stay for admitted patients when using this treatment model (3-4). Its safety profile has been proven in various studies (1-4). Numerous scientific investigations have been conducted on biological mechanism of action of ESWT in animals and humans and both proved to be safe and effective (5-6). Furthermore, it has been demonstrated that ESWT therapy achieves long-term healing results in diabetic wound care (7). Thus using this technology at The Townsville Hospital would likely improve the weighted activity unit per bed day figure for medical patients by increasing the total bed days saved, as that capacity will be filled by current access block / unmet demand of the chronic diabetic foot wounds at the hospital. In spite of these facts, ESWT technology has not been utilised in the care of diabetic foot ulcer patients in Australia in general and at The Townsville Hospital in particular. This is despite the fact that this technology is non-invasive, simple to use, well tolerated by patients, and only needs to be administered on fortnightly basis whereas even more invasive therapies need more frequent administration. Furthermore, ESWT is applied through an unfocused applicator which assures an almost painless treatment with no anaesthesia required and each therapy session only taking about 10 to 30 minutes. The main objective of this study was to evaluate wound healing rate and anti-inflammatory effect of shockwave therapy in subjects with diabetic foot ulcer at the Townsville Hospital, Australia. References 1. Wang C, Kuo Y, Wu R et al. J Surg Res. 2009; 152: 96-103. 2. Moretti B, Notarnicola A. et al. BMC Musculoskeletal Disorders 2009, 10:54, 1-8. 3. Wang CJ, Wu RW, Yang YJ. Diabetes Res Clin Pract. 2011 ;92(2):187-93. 4. Saggini R, Figus A, et al.. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. 5. Mittermayr R, Antonic V, et al. Wound Repair Regen. 2012;20(4):456-65. 6. Kuo YR, Wang CT, et al. Wound Repair Regen. 2009;17(4):522-30. 7. Wang CJ et al. J Surg Res. 2014;189(2):366-72.
Interventions
Twenty five subjects with diabetic foot ulcer will be treated fortnightly with standard 20-minute wound care (debridement and normal saline dressing) first, to be followed by 10 minutes of shockwave therapy for a period of 6 weeks. A handheld shockwave device will be applied gently against the ulcer surface by treating podiatrist to deliver 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density during which the participant may feel light vibration and then crossover for another 6
Twenty five subjects with diabetic foot ulcer will be treated fortnightly with standard 20-minute wound care (debridement and normal saline dressing) first, to be followed by 10 minutes of shockwave therapy for a period of 6 weeks. A handheld shockwave device will be applied gently against the ulcer surface by treating podiatrist to deliver 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density during which the participant may feel light vibration and then crossover for another 6 weeks on fortnightly standard wound care alone with total duration of the study period of 12 weeks. Log of device use time will be utilized to monitor adherence of the shockwave therapy.
Sponsors
The Townsville Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diabetes age >18 years 2. Stable documented diabetic foot ulcer of full-thickness skin defect requiring >14 days of healing. 3. Exclusion of other etiologies of foot ulcer.
Exclusion criteria
1. Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.). 2. Any major surgery up to 4 weeks prior to the day of enrolment or any planned surgery prior to study completion including any major surgical intervention for the diabetic foot ulcer. 3. Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g. Lupus erythematodes, scleroderma, etc.), chronic inflammatory diseases (e.g. inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma. 4. Treatment with normothermic or hyperbaric oxygen therapy. 5. Skin and dermal substitutes within 30 days prior to study enrolment. 6. Enzymatic debridement treatment. 7. Participation in any other clinical trial. 8. Inability to comply with study protocol.
Outcome results
None listed