Low Concentration ALA-PDT in Treatment of Skin Ulcer

NCT04689243 | Unknown

• 1 other identifier: 2018QN02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Ulcer; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• ulcer area size

  The ulcer area size was measured

  Change from Baseline ulcer area size at 24 hours after the last treatment.

Secondary Outcomes (1)

• total bacterial load

  Change from Baseline total bacterial load at 24 hours after the last treatment.

Study Arms (2)

ALA-PDT

EXPERIMENTAL

Procedure: ALA-PDT

red light

OTHER

Procedure: red light

Interventions

ALA-PDT PROCEDURE

Low concentration ALA-PDT, 3 times a week.

ALA-PDT

red light PROCEDURE

red light, 3 times a week.

red light

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610031, China

RECRUITING

MeSH Terms

Conditions

Skin Ulcer

Interventions

Red Light

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Central Study Contacts

Yujie Mao, M.D.

CONTACT

(86)02887393999; yujiemao@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2019
• Primary Completion: December 26, 2020
• Study Completion: December 30, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

CN (1)