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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
Sichuan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Ulcer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 23, 2020
Last Updated
December 29, 2020
Sponsor
Sichuan Provincial People's Hospital
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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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