Low Concentration ALA-PDT in Treatment of Skin Ulcer

Study Overview
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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.

Official Title
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Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer

Conditions
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Skin Ulcer, Photodynamic Therapy

Intervention / Treatment
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* Procedure: ALA-PDT
* Procedure: red light


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA-PDT<br> | Procedure: ALA-PDT<br>* Low concentration ALA-PDT, 3 times a week.<br>|
| Other: red light<br> | Procedure: red light<br>* red light, 3 times a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer area size | The ulcer area size was measured | Change from Baseline ulcer area size at 24 hours after the last treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total bacterial load | Levels of total bacteria were tested | Change from Baseline total bacterial load at 24 hours after the last treatment. |