None listed
Conditions
Brief summary
There is a little research in Saudi Arabia on diabetic foot ulcer (DFU) prevalence, management or cost. However, surveys suggested that the incidence of diabetes is 23.7%, and it is extremely higher in urban areas. The diabetic foot lesions constitute a major complication with an overall prevalence of 10.4%. Those lesions are linked with increased health cost, diminished quality of life, and prolong functional disability. Many adjunctive therapies are designed for the care of DFU, involving hyperbaric oxygen therapy, vacuum-assisted wound closure, low level laser therapy and electrical stimulation. However, the results from these studies are inconsistent and reported limited success with no conclusive remark on its use. Therefore, the development of new effective noninvasive modalities for management of diabetic wounds is extremely important to reduce both patients' suffering from chronic wounds and the cost of treatment. For the past 20 years, extracorporal shockwave therapy (SWT) has been used for the wide range of musculoskeletal disorders. Recently, SWT was shown to be valuable for treatment of chronic wound, such as bedsores, vascular and diabetic ulcers burn wounds and skin flaps. However, these studies were limited clinical trials with the low level of evidence in respect to the criteria of the Center for Evidence-Based Medicine. Moreover, systematic review concluded that lack of evidence and rigorous study design made it difficult for clinicians and therapists to support using of SWT in wound healing. Furthermore, clinical trials are required to assess the optimum SWT treatment parameters, such as duration and frequency of therapy and types of wound remains. Therefore, this single blinded, randomized controlled study was conducted to examine the efficacy of SWT on the healing rate and wound surface area (WSA) in chronic diabetic foot ulcers.
Interventions
shock wave therapy (SWT-group): The ulcer had been cleaned with saline, and the necrotic tissues had been removed, and the ulcer had dried before application of SWT. To avoid cross-contamination, each ulcer was covered with a sterilized transparent plastic thin film that allows 100% transmission of waves through it. Ultrasound gel was applied to the area on the skin in contact with the shock wave probe. Patients received SWT at frequency of 100 pulse/cm2, and energy flux density of 0.11mJ/cm2. T
shock wave therapy (SWT-group): The ulcer had been cleaned with saline, and the necrotic tissues had been removed, and the ulcer had dried before application of SWT. To avoid cross-contamination, each ulcer was covered with a sterilized transparent plastic thin film that allows 100% transmission of waves through it. Ultrasound gel was applied to the area on the skin in contact with the shock wave probe. Patients received SWT at frequency of 100 pulse/cm2, and energy flux density of 0.11mJ/cm2. The probe was held vertically against each ulcer by direct contact with slight pressure to minimize power loss due to beam divergence. After each session, the therapist inspected the area surrounding ulcer for adverse events such as dermatitis, erythema, infection, excessive granulation and necrotic tissue. The SWT was applied once a week, with one-week interval, and with a minimum of four and a maximum of eight sessions base on healing rate. duration that SWT was applied at each session depend on wound surface area (5-10minutes). In addition, patients received standardized wound care consisting of debridement, blood-glucose control agents, and footwear modification for pressure reduction. Wound dressing was changed once a day by the patient, their family members, or home-health care providers, depending on the patient’s individual capabilities and resources.
Sponsors
king Saud university, Rehabilitation Research Chair
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients who met the following criteria were included in this study: (1) diagnosis of type I and II diabetes; (2) Grade 2 diabetic foot ulcer (DFU) according to the University of Texas Diabetic Foot Wound Classification System (wound penetrating to tendon or capsule, not involving bone or joint); (3) ulcer has been resisted to conservative treatment > 3 months; (4) ulcer measures > 0.5cm and < 5 cm at any dimension; (5) patient should have had peripheral neuropathy, as defined by insensitivity to a 10-g monofilament and (6) patient should be willing to participate in the study and comply with the follow-up.
Exclusion criteria
Patients were excluded if they had: (1) evidence of local infection, acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity; (2) presence of renal, hepatic, neurologic or malignant diseases; (3) severe protein malnutrition (serum albumin < 2.0 g/dl) or severe anemia (Hgb < 7.0 g/dl); (4) an ankle-brachial index < 0.7, absence of the dorsalis pedis or posterior tibial arteries pulse; or (5) pregnancy.
Outcome results
None listed