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Trial registered on ANZCTR


Registration number
ACTRN12613000355774
Ethics application status
Approved
Date submitted
27/03/2013
Date registered
4/04/2013
Date last updated
4/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
diabetic foot ulcer and shock wave therapy
Scientific title
Efficacy of Shock Wave Therapy on Chronic Diabetic Foot Ulcer: A Single-Blinded Randomized Controlled Clinical Trial
Secondary ID [1] 282194 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcer 288706 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289055 289055 0 0
Physiotherapy
Metabolic and Endocrine 289075 289075 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286800 0
Treatment: Other
Intervention code [2] 286817 0
Treatment: Devices
Comparator / control treatment
patients in the control group 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.
Control group
Active

Outcomes
Primary outcome [1] 289170 0
1-Wound surface area measurement
The percentage of decrease in wound surface area (WSA) due to interventions was recorded. The therapist placed sterilized transparency sheet over the wound and traced the wound perimeter using a permanent marking pen. Each wound was traced three times to ensure the reliability of measurement. The tracing was digitalized using the A4 G-Note 7100 tablet with cordless mouse and two stylus pen (KYE systems, Corp, China), and then imported to a specialized software program (Photoshop C4me) to calculate WSA. The percentage of reduction in WSA was determined from the following equation:

%WSA = [initial WSA (cm2) - WSA (cm2) at x weeks] X100
initial WSA (cm2)
The percentage of wounds that had completely healed was detected at each measurement time. The wounds were labeled completely healed only if they clinically closed (100% re-epithelization) without drainage or dressing requirement.
Timepoint [1] 289170 0
The percentage of reduction in WSA was calculated after the end of interventions 8-week and after 20-week follow-up assessment.
Primary outcome [2] 289183 0
The time to complete healing
it was recorded as the number of days from the beginning of the treatment to the date in which the wound achieved complete healing. If healing did not occur within the 20 weeks, the patient was considered to be nonhealing and no time was recorded.
Timepoint [2] 289183 0
time was recorded at 8 weeks, at 20 weeks follow-up
Secondary outcome [1] 301955 0
Wound bed preparation scores
The wound bed preparation scores and the percentage of granulation and necrotic tissues and presence of the exudates have been determined. The presence of exudates was determined as: none, minimal, moderate and heavy, based on wound bed preparation scores developed by Falanga et al .
Timepoint [1] 301955 0
it was calculated after the end of interventions 8-week and after 20-week follow-up assessment.

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited from the general surgery department and the outpatient clinic, King Saud Medical City, Riyadh, Saudi Arabia. The study was approved by the Research Ethics Committee at King Saud Medical City.
The randomization was completed by generating blocks of numbers. The numbers were assigned as a treatment group and sealed in opaque envelopes containing black paper labeled with treatment received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A single-blinded, randomized controlled study was conducted from May 2010 to September 2012.

we generated a computerized random number list and the subject allocation.
sequence was created from the list.Therapist who evaluated patients and analyzed data were blinded to the treatment received.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Continuous variables were presented as mean and standard deviation while categorical variables were described by frequency and percentage.
Because most of the measured data were not normally distributed, nonparametric tests had been used for analyses. The Wilcoxon test was used to test the differences in outcome measures within group. The Mann–Whitney U test was used for comparison between the groups. Significant differences were assumed at p <0.05. Statistical analyses were performed using Statistical Package for the Social Sciences (SPSS) version 17.0).
Based on type I error, probability set at 0.05, with 90% power, detection of 20% differences between treatment groups required 19 patients for both groups(total of 38 patients). The sample size would be increased to 45 for possible dropout.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4956 0
Saudi Arabia
State/province [1] 4956 0
Riyadh

Funding & Sponsors
Funding source category [1] 286959 0
University
Name [1] 286959 0
Rehabilitation Research Chair, king Saud University
Address [1] 286959 0
Rehabilitation Research Chair
King Saud University
Riyadh, Saudi Arabia
P.O. Box, 10219, Riyadh, 11433

Country [1] 286959 0
Saudi Arabia
Primary sponsor type
University
Name
king Saud university, Rehabilitation Research Chair
Address
Rehabilitation Research Chair
King Saud University
Riyadh, Saudi Arabia
P.O. Box, 10219, Riyadh, 11433

Country
Saudi Arabia
Secondary sponsor category [1] 285744 0
Hospital
Name [1] 285744 0
King Saud Medical City, Riyadh, Saudi Arabia
Address [1] 285744 0
King Saud Medical City, Riyadh, Saudi Arabia
Riyadh, Saudi Arabia
P.O. Box, 2897, Riyadh, 11196
Country [1] 285744 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289008 0
Research Ethics Committee at King Saud Medical City
Ethics committee address [1] 289008 0
King Saud Medical City, Riyadh, Saudi Arabia.
king Abdullaha road,Riyadh
P.o.Box 2897, Riyadh, 11196
Ethics committee country [1] 289008 0
Saudi Arabia
Date submitted for ethics approval [1] 289008 0
11/01/2011
Approval date [1] 289008 0
14/04/2011
Ethics approval number [1] 289008 0

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38778 0
A/Prof Mohammed Taher Ahmed Omar
Address 38778 0
Rehabilitation Sciences Department
College of Applied Medical Sciences
King Saud University
Riyadh, Saudi Arabia
P.O. Box, 10219, Riyadh, 11433
Country 38778 0
Saudi Arabia
Phone 38778 0
+966542115404
Fax 38778 0
Email 38778 0
momarar@cu.edu.eg
Contact person for public queries
Name 38779 0
A/Prof Mohammed Taher Ahmed Omar
Address 38779 0
Rehabilitation Sciences Department
College of Applied Medical Sciences
King Saud University
Riyadh, Saudi Arabia
P.O. Box, 10219, Riyadh, 11433
Country 38779 0
Saudi Arabia
Phone 38779 0
+966542115404
Fax 38779 0
Email 38779 0
momarar@cu.edu.eg
Contact person for scientific queries
Name 38780 0
A/Prof Mohammed Taher Ahmed Omar
Address 38780 0
Rehabilitation Sciences Department
College of Applied Medical Sciences
King Saud University
Riyadh, Saudi Arabia
P.O. Box, 10219, Riyadh, 11433
Country 38780 0
Saudi Arabia
Phone 38780 0
+966542115404
Fax 38780 0
Email 38780 0
momarar@cu.edu.eg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary