This study is a randomized clinical trial for comparison of evaluation diabetic foot ulcer debridement with the help of ultrasonic waves compared with sharp debridement with regard to rate of wound healing (complete epithelization without septic drainage) in 40 diabetic patients with chronic wounds (grade: Wegener 3). Patients have been referred to diabetes clinic of Shariati hospital in Tehran. Inclusion criteria: - patients with diabetic foot ulcers are classified according to Wagner with 3 grades (without necrotizing fasciatis or joint infection). – Patient’s satisfaction and cooperation - ABI =. 5-1.2, Toe pressure> 50 mmHg. Exclusion criteria from the study: - diabetic foot patients that classification of ulcer based on Wagner is higher than 3 grade or with necrotizing fascitis and joint infection. - Metal elements such as artificial joints, plate and screws and electronic devices are implanted in the wound. Ultrasonic wound debridement is done using device called Sonoca 180 manufacturing Soring Company in Germany. This device works with low-frequency ultrasonic waves around 24 Hz with three different props that has been designed according to the shape and type of wound and are connected to a serum containing 9% saline. Normal saline is sprayed on the surface of the wound with adjustable speed with simultaneous debridement and dissemination of Ultrasound waves. Because ultrasonic waves require moist environment and also cause necrotic and infected material to be cleaned out and props become cool. Number of debridements during the study can be determined based on both grade and speed wound healing. Study outcome measures: Evaluation of wound healing without damage to healthy tissue, pain during Debridement , bacticidal effect and relationship of these three factors with ischemic conditions and neuropathy and other risk factors of diabetic foot ulcers in two ways of debridement (Sharp - ultrasonic)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903271414N21
Registration date:2010-06-17, 1389/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-17, 1389/03/27
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrine & metabolic research institute-Tehran university of medicak science -Kavosh Pasand Novin Company
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of ultrasonic wound debridement in diabetic foot ulcers
Public title
comparison between ultrasonic wound debridement and sharp debridement in diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-patients with known type 1 &2 diabetes
- Diabetic patients with chronic and none healing foot ulcers that need continual debridement
-diabetic patients with diabetic foot ulcer (3 Wagner’s grade without necrosis fashiatis or contiguous joint infection)
-patient's assistance
- ABI=.5-1.2, TOE PRESSURE>50 mmHg
Exclusion criteria:
Diabetic patients with (Wagner’s grade>3 with necrosis fashiatis or contiguous joint infection)
-being metal devices in foot ulcer such as false joint, nail or metal plate, electrical tools
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine & metabolic research institute-Tehran university of medicak science
Street address
Shariati Hospital-North Kargar street-
City
Tehran
Postal code
1411413137
Approval date
empty
Ethics committee reference number
E-0055
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer
ICD-10 code
Z86.31
ICD-10 code description
personal history of diabetic foot ulcer
Primary outcomes
1
Description
Rate of healing
Timepoint
1, 3, 6 months after beginning of debridement or Intervention
Method of measurement
wound area calculation
Secondary outcomes
1
Description
Bactericidal effect
Timepoint
Before and after first wound debridement and final wound debridement
Method of measurement
Colony count
2
Description
Pain Evaluation
Timepoint
after every wound debridement
Method of measurement
visual analogue scale
Intervention groups
1
Description
Intervention group Debridement is done with the help of ultrasonic waves and wet dressing with gas is carried out.Normally debridement is done once a week unless the situation is so wound that required debridement performed twice a week . The long-term study is at least 6 months and maximum until wound healing is complete.
Category
Treatment - Surgery
2
Description
Control group is similar to intervention group and only differ in the type of debridement that is performed with surgical blade
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic foot clinic located in diabetes and metabolic center-shariati Hospital
Full name of responsible person
Dr. Sareh Amini -researcher
Street address
Beside emergency door of heart center; North Kargar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrine & metabolic research institute-Tehran university of medicak science
Full name of responsible person
Dr.Bagher Larijani Presidency of Endocrine & metabolic research institute
Street address
Shariati Hospital, North Kargar st.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine & metabolic research institute-Tehran university of medicak science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Kavosh Pasand Novin Company
Full name of responsible person
Meisam Alikhani
Street address
No 6, Oraman Street, South Sohrevardi
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kavosh Pasand Novin Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrine & metabolic research institute
Full name of responsible person
Dr. Mohamadreza Mohajrri
Position
Endocrinologist-assistant of endocrine research center
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar st.,
City
Tehran
Postal code
1411413137
Phone
00982188220037; 00982188220038
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
emrc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Endocrine & metabolic research institute
Full name of responsible person
Dr. Sareh Amini - researcher
Position
General Physician-researcher
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar st.,
City
Tehran
Postal code
1411413137
Phone
00982188220037; 00982188220038
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Web page address
emrc.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)