Low Concentration ALA-PDT in Treatment of Skin Ulcer
Primary Purpose
Skin Ulcer, Photodynamic Therapy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ALA-PDT
red light
Sponsored by
About this trial
This is an interventional treatment trial for Skin Ulcer
Eligibility Criteria
Inclusion Criteria:
- chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing
Exclusion Criteria:
- allergies to photosensitizers and their solvents, serious medical illnesses, such as severe heart disease, severe liver or kidney dysfunction, systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent, the use of topical or systemic antibiotics within one month prior to treatment. Pregnant or lactating women were also excluded.
Sites / Locations
- Sichuan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ALA-PDT
red light
Arm Description
Outcomes
Primary Outcome Measures
ulcer area size
The ulcer area size was measured
Secondary Outcome Measures
total bacterial load
Levels of total bacteria were tested
Full Information
NCT ID
NCT04689243
First Posted
December 23, 2020
Last Updated
December 29, 2020
Sponsor
Sichuan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04689243
Brief Title
Low Concentration ALA-PDT in Treatment of Skin Ulcer
Official Title
Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 26, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Ulcer, Photodynamic Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALA-PDT
Arm Type
Experimental
Arm Title
red light
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
ALA-PDT
Intervention Description
Low concentration ALA-PDT, 3 times a week.
Intervention Type
Procedure
Intervention Name(s)
red light
Intervention Description
red light, 3 times a week.
Primary Outcome Measure Information:
Title
ulcer area size
Description
The ulcer area size was measured
Time Frame
Change from Baseline ulcer area size at 24 hours after the last treatment.
Secondary Outcome Measure Information:
Title
total bacterial load
Description
Levels of total bacteria were tested
Time Frame
Change from Baseline total bacterial load at 24 hours after the last treatment.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing
Exclusion Criteria:
allergies to photosensitizers and their solvents, serious medical illnesses, such as severe heart disease, severe liver or kidney dysfunction, systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent, the use of topical or systemic antibiotics within one month prior to treatment. Pregnant or lactating women were also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujie Mao, M.D.
Phone
(86)02887393999
Email
yujiemao@yeah.net
Facility Information:
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujie Mao
Phone
(86)02887393999
Email
yujiemao@yeah.net
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low Concentration ALA-PDT in Treatment of Skin Ulcer
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