Protocol summary

Study aim
The efficacy and safety of atmospheric pressure plasma versus low-level laser therapy on chronic wounds (including dystrophic epidermolysis bullosa)
Design
In this clinical trial, 6 patients with Dystrophic EB will be included and in each patient 5 wounds will be randomly selected for different kinds of treatment. In each patient, 2 wounds will be treated with plasma, 2 wounds with low level laser and one was dressed with standard wound care as the control.
Settings and conduct
The quality of wound healing will be assessed by evaluation of wound size and also a designed qualitative wound score (QWS), which evaluate the healing by scoring changes in four parameters as follows: (i) size (scores of 0, 1, and 2, indicating decreased size, no change or increased size, respectively); (ii) odour (0, no and 1, yes); (iii) exudate (scores of 0, 1 and 2 indicating none, mild and moderate to severe, respectively); and (iv) redness (scores of 0, 1 and 2 indicating none, pink and red, respectively). A dermatologist who is unaware of the assigned treatment for each lesion, recruit to assess the lesions before treatment, after each session of treatment (during treatment), 2, 6 and 12 weeks after treatment
Participants/Inclusion and exclusion criteria
- Inclusion criteria: Dystrophic EB patients with age over 10 years, old chronic wounds over 3 months, Full satisfaction for entrance to the study, without exclusion criteria - Exclusion criteria: Other comorbidities including collagen vascular diseases and vasculitis, coronary artery diseases, active infection, malignancy on the treatment area, Alcoholics and smokers
Intervention groups
Dystrophic EB patients who have old chronic wounds over 3 months with no response to conventional treatments
Main outcome variables
Time of complete wound healing Dermatology Life Quality Index Qualitative wound score (QWS) Recurrence time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160320027109N2
Registration date: 2018-12-02, 1397/09/11
Registration timing: retrospective

Last update: 2018-12-02, 1397/09/11
Update count: 0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Fahimeh Abdollahimajd
Name of organization / entity
Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
fabdollahimajd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-04, 1397/08/13
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-01-14, 1396/10/24
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
empty
Scientific title
The efficacy and safety of atmospheric pressure plasma versus low-level laser therapy on chronic wounds (including dystrophic epidermolysis bullosa)
Public title
The efficacy of atmospheric pressure plasma versus low-level laser on chronic wounds (including epidermolysis bullosa)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 10 years old Chronic wounds over 3 months Without exclusion criteria Full satisfaction for entrance to the study
Exclusion criteria:
Other comorbidities including collagen vascular diseases and vasculitis Coronary artery diseases Active infection malignancy in the treatment area Alcoholics and smokers
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 6
More than 1 sample in each individual
Number of samples in each individual: 5
For each patient, 2 wounds for plasma therapy, 2 wounds for laser therapy and 1 wound with standard wound dressing as a control
Actual sample size reached: 6
More than 1 sample in each individual
Actual sample size in each individual: 5
For each patient, 2 wounds for plasma therapy, 2 wounds for laser therapy and 1 wound with common wound dressing
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Data analysis will be done by a dermatologist who is unaware of the assigned treatment for each lesion
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Skin Research Center,Shahid Beheshti University of Medical Sciences
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2016-02-02, 1394/11/13
Ethics committee reference number
IR.SBMU.SRC.REC.1394.13

Health conditions studied

1

Description of health condition studied
Dystrophic epidermolysis bullosa
ICD-10 code
Q81.2
ICD-10 code description
Epidermolysis bullosa dystrophica

Primary outcomes

1

Description
The wound size
Timepoint
Before treatment, after each session of treatment (during treatment), 2, 6 and 12 weeks after treatment
Method of measurement
Photography, Qualitative Wound Score, imagej software

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and just after treatment, 12 weeks after the last session of treatment
Method of measurement
the Dermatology Life Quality Index (DLQI)

Intervention groups

1

Description
Intervention group: In each patient, 2 wounds will be selected and treated with plasma twice a week until complete improvement (or average 8 weeks) and the wounds will be evaluated in each session of treatment, 2 , 6 and 12 weeks after the last session of treatment.
Category
Treatment - Other

2

Description
Intervention group: In each patient, 2 wounds will be selected and treated with low level laser twice a week until complete improvement (or average 8 weeks) and the wounds will be evaluated in each session of treatment, 2 , 6 and 12 weeks after the last session of treatment.
Category
Treatment - Other

3

Description
Control group: In each patient, one wound will be selected and treated with standard wound care (as a control) twice a week until complete improvement (or average 8 weeks) and the wounds will be evaluated in each session of treatment, 2 , 6 and 12 weeks after the last session of treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Shohada-e Tajrish Hospital
Full name of responsible person
Fahimeh Abdollahimajd
Street address
Shohada-e Tajrish Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
fabdollahimajd@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin Research Center, Shahid Beheshti University of Medical Science
Full name of responsible person
Dr Parviz Toossi
Street address
Skin Research Center, Shohada-e Tajrish Hospital, Qods sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
fabdollahimajd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin Research Center, Shahid Beheshti University of Medical Science
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Reza Shakouri
Position
Skin expert of plasma in Fanavar Jam Company
Latest degree
Master
Other areas of specialty/work
Plasma physics
Street address
Daneshjou Blvd, District 1, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 4017
Email
Shakouri.rsh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Abdollahimajd
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
fabdollahimajd@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Shirin Samsavar
Position
Skin expert of plasma fanavar jam company
Latest degree
Bachelor
Other areas of specialty/work
Plasma physics
Street address
Daneshjou Blvd, District 1, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 4017
Email
Shirinsamsavar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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