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Low Concentration ALA-PDT in Treatment of Skin Ulcer

NCT ID: NCT04689243

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Ulcer Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALA-PDT

Group Type EXPERIMENTAL

ALA-PDT

Intervention Type PROCEDURE

Low concentration ALA-PDT, 3 times a week.

red light

Group Type OTHER

red light

Intervention Type PROCEDURE

red light, 3 times a week.

Interventions

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ALA-PDT

Low concentration ALA-PDT, 3 times a week.

Intervention Type PROCEDURE

red light

red light, 3 times a week.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yujie Mao

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yujie Mao, M.D.

Role: CONTACT

Phone: (86)02887393999

Email: [email protected]

Facility Contacts

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Yujie Mao

Role: primary

Other Identifiers

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2018QN02

Identifier Type: -

Identifier Source: org_study_id