None listed
Conditions
Brief summary
Electromagnetic stimulator therapy (EMST) is a new technology in the care of chronic non-healing wounds [1]. The technology delivers high-energy pressure waves into the wound by enriching the ulcer with adequate blood through formation of new blood vessels. It also stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound [2]. Recently, EMST was reported to be effective in the initiation and acceleration of wound healing in various non-diabetic clinical settings most part involves small case series of bed sores and venous ulcers with scanty reports on diabetic wounds [1-2]. Thus, there is very little information on effect of electromagnetic stimulation in healing ulcers of diabetic foot. With our earlier report of high rate of diabetic limb amputations in our local population [3-4] we believe EMST technology may have a role to play in the care of our patients. This technology is simple and can be administered fortnightly as against daily administration in other form of therapies. The treatment with EMST is a non-invasive method and easily tolerated by patients. It is applied through an unfocused applicator which assures an almost painless treatment and no anaesthesia required. Each therapy session only takes about 15 to 60 minutes. As EMST being a viable option of diabetic foot ulcer (DFU) care in our high risk diabetic population yet there is no study to show EMST usefulness in treatment of non-healing DFU in Australia. It would be interesting to find out if this technology would change our current daily diabetic foot ulcer care practice for the betterment of the most costly diabetic complications -DFU. The main objective of the study was to evaluate the healing rates of chronic diabetic foot ulcers during a 12-week period in patients treated with EMST and usual care compared to usual care alone. Reference 1. Gaurav Thakral et al. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013; 4: 10.3402/dfa.v4i0.22081. 2. Jhamb S, Vangaveti VN, Malabu UH. Genetic and molecular basis of diabetic foot ulcers: Clinical review. J Tissue Viability. 2016. pii: S0965-206X(16)30041-9. 3. Rodrigues BT, Vangaveti VN, Malabu UH. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study. J Diabetes Res. 2016;2016:5941957. 4. Gilhotra RA, Rodrigues BT, Vangaveti VN, Kan G, Porter D, Sangla KS, Malabu UH. Non-traumatic lower limb amputation in patients with end-stage renal failure on dialysis: an Australian perspective. Ren Fail. 2016 Aug;38(7):1036-43.
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 40 minutes of electromagnetic stimulator therapy for a period of 6 weeks. An electromagnetic stimulator probe will be applied gently against the ulcer surface by treating podiatrist to deliver 150 V, 100 micro, 100 Hz during which the participant may feel light vibration and then crossover for another 6 weeks on fortnightly
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 40 minutes of electromagnetic stimulator therapy for a period of 6 weeks. An electromagnetic stimulator probe will be applied gently against the ulcer surface by treating podiatrist to deliver 150 V, 100 micro, 100 Hz during which the participant may feel light vibration and then crossover for another 6 weeks on fortnightly standard 20-minute 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 electromagnetic stimulator 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. Subjects with pacemaker or implantable defibrillators 9. Inability to comply with study protocol.
Outcome results
None listed