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Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: human fibroblast-derived dermal substitute(sinaderm)
Control group: wet dressing by Normal saline
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Main outcome variables
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Percentage of change in wound area compared to baseline
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190210042676N7
Registration date:
2020-05-19, 1399/02/30
Registration timing:
prospective
Last update:
2023-02-09, 1401/11/20
Update count:
2
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Registration date
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2020-05-19, 1399/02/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-21, 1399/03/01
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Expected recruitment end date
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2021-04-09, 1400/01/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluation of efficacy and safety of dermal substitute (Sinaderm)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-29, 1399/02/10
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.312
Health conditions studied
1
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Description of health condition studied
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Personal history of diabetic foot ulcer
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ICD-10 code
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Z86.31
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ICD-10 code description
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Personal history of diabetic foot ulcer
Primary outcomes
1
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Description
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Area of wound compared to baseline
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Timepoint
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Before the intervention and once a week for 8 weeks
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Method of measurement
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Checkered paper
Secondary outcomes
1
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Description
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The percentage of patients who responded 50% to treatment
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Timepoint
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Once a week for 8 weeks
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Method of measurement
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counting the respounders
2
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Description
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Patients' satisfaction
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Timepoint
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Once a week for 8 weeks
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Method of measurement
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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
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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Control group: wet dressing by Normal saline which will be changed every 24 hours till complete wound healing.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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sinacell enterprise knowledge management
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable