Evaluation of efficacy and safety of Sinaderm dermal substitute plus standard treatment (wet dressing) comparing standard treatment alone for healing chronic lower extremity diabetic ulcers
Evaluation of efficacy and safety of Sinaderm dermal substitute plus standard treatment (wet dressing) comparing standard treatment alone for healing chronic lower extremity diabetic ulcers
Design
parallel group, phase 3, parallel treatment-control clinical study. sample size is 68. The study is randomized and one-way blind. An online site (https://www.sealedenvelope.com) will be used to randomization.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy. 68 volunteers will be selected and enrolled in the study after signing consent form. subjects will be enrolled to one of intervention groups acoording to the randomization list ( Sinaderm dermal substitute plus standard treatment (wet dressing) comparing standard treatment alone). The evaluation will perform based on the Wagner calcification before the intervention and once a week for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Signing the consent form for participation in the study
patients with type I or II diabetes mellitus and neuropathy disorder 3 (defined by Michigan diabetic neuropathy score)
At least 1, but no more than 2, partial thickness neuropathic ulcer (stage I and II as defined by Wagner staging system) located on the lateral foot, plantar arch, forefoot, , heel, or toe.
Exclusion criteria:
Patients with ulcers resulting from electrical, chemical, or radiation burns or venous insufficiency
Patients with ulcers resulting from amputation
Uncontrolled infection or necrosis or cellulitis at the site of the target ulcer
Uncontrolled hyperglycemia (HbA1c > 10%)
Pregnancy or lactating
Intervention groups
Intervention group: human fibroblast-derived dermal substitute(sinaderm)
Control group: wet dressing by Normal saline
Main outcome variables
Percentage of change in wound area compared to baseline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N7
Registration date:2020-05-19, 1399/02/30
Registration timing:prospective
Last update:2020-05-19, 1399/02/30
Update count:2
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of Sinaderm dermal substitute plus standard treatment (wet dressing) comparing standard treatment alone for healing chronic lower extremity diabetic ulcers
Public title
Evaluation of efficacy and safety of dermal substitute (Sinaderm)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing the consent form for participation in the study
Men or women with type I or II diabetes mellitus and neuropathy disorder 3 (defined by Michigan diabetic neuropathy score)
At least 1, but no more than 2, partial thickness neuropathic ulcer (stage I and II as defined by Wagner staging system) located on the lateral foot, plantar arch, forefoot, , heel, or toe
The target ulcer have an area, after debridement between 3 and 25 cm2
The target ulcer has been present for at least 4 weeks at the time of the baseline visit
Exclusion criteria:
Patients with ulcers resulting from electrical, chemical, or radiation burns or venous insufficiency
Patients with ulcers resulting from amputation
Uncontrolled infection or necrosis or cellulitis at the site of the target ulcer
Chronic renal insufficiency (serum creatinine > 2.5)
Uncontrolled hyperglycemia (HbA1c > 10%)
Administration of some medications (chemotherapy, immune suppressants, corticosteroids or radiotherapy) within past 30 days
Pregnancy or lactating
Heavy smokers
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
An online site (https://www.sealedenvelope.com) will be used to generate a randomized list of study groups. According to the random block method and considering the four blocks, 17 blocks will be produced for 68patients.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.TUMS.VCR.REC.1399.312
Health conditions studied
1
Description of health condition studied
Personal history of diabetic foot ulcer
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Area of wound compared to baseline
Timepoint
Before the intervention and once a week for 8 weeks
Method of measurement
Checkered paper
Secondary outcomes
1
Description
The percentage of patients who responded 50% to treatment
Timepoint
Once a week for 8 weeks
Method of measurement
counting the respounders
2
Description
Patients' satisfaction
Timepoint
Once a week for 8 weeks
Method of measurement
Questionnaire.Patent will declare his or her satisfaction in case of the compatibility of the dressings , its help to reduce the pain and also improving the wound using five-grade Likert scale (5= extremely satisfied, 4= very satisfied, 3= moderately satisfied, 2= slightly satisfied, 1= dissatisfied)
Intervention groups
1
Description
Intervention group: human fibroblast-derived dermal substitute(sinaderm) plus wet dressing. sinaderm will be inserted once or twice according to physician opinion and wet dressing will be inserted over it. wet dressing will be changed each 72 hours till complete wound healing.
Category
Treatment - Devices
2
Description
Control group: wet dressing by Normal saline which will be changed every 24 hours till complete wound healing.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Shahid Naderi (Soheil) St. Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
sinacell enterprise knowledge management
Full name of responsible person
Mohammad Soleimani
Street address
No.162,16th innovation streePardis technology campus, 20 km of Abali road
City
Tehran
Province
Tehran
Postal code
1654120596
Phone
+98 21 7625 0661
Email
info@sinacellco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?