Skin UlcerNCT04689243
Low Concentration ALA-PDT in Treatment of Skin Ulcer
A study testing ALA-PDT and red light in people with Skin Ulcer and Photodynamic Therapy, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Ulcer, Photodynamic Therapy
- What is being tested?
- ALA-PDT and red light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610031
Yujie Mao, (86)02887393999, yujiemao@yeah.net
About this study
Official title: Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer
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
- Being tested
- ALA-PDT, red light
- Medical subject headings
- Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA-PDTProcedure or surgery
Low concentration ALA-PDT, 3 times a week.
red lightProcedure or surgery
red light, 3 times a week.
| Study group | Role | What they receive |
|---|---|---|
| ALA-PDT | Experimental | Not described Receives: Procedure: ALA-PDT |
| red light | Other | Not described Receives: Procedure: red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer area size
The ulcer area size was measured
Measured: Change from Baseline ulcer area size at 24 hours after the last treatment.
Secondary outcomes (1)
total bacterial load
Levels of total bacteria were tested
Measured: Change from Baseline total bacterial load at 24 hours after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2019
- Primary completion26 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Mao, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689243
- Sponsor's protocol ID
- 2018QN02
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer
- ClinicalTrials.gov ID
- NCT04689243
- Acronym / sponsor ID
- 2018QN02
- Conditions
- Skin Ulcer, Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 26 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA-PDT | Experimental | Procedure: ALA-PDT |
| red light | Other | Procedure: red light |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALA-PDTLow concentration ALA-PDT, 3 times a week. | Procedure or surgery | ALA-PDT |
| red lightred light, 3 times a week. | Procedure or surgery | red light |
Primary outcome
ulcer area size
Time frame: Change from Baseline ulcer area size at 24 hours after the last treatment.
The ulcer area size was measured
1 secondary outcome
total bacterial load
Time frame: Change from Baseline total bacterial load at 24 hours after the last treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALA-PDT and red light in people with Skin Ulcer and Photodynamic Therapy, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Mao, M.D. ((86)02887393999, yujiemao@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer area size (time frame: Change from Baseline ulcer area size at 24 hours after the last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.