Diabetic Extremity Lower UlcersNCT03222544
Clinical Study of Methylene Blue - Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer
A study testing methylene blue and Photon therapy instrument in people with Diabetic Extremity Lower Ulcers, run by Chongqing Medical University at 1 site in China.
Trial summary
The investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Extremity Lower Ulcers
- What is being tested?
- methylene blue and Photon therapy instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2019to 29 Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Understand the whole test process, voluntary and signed informed consent form.
- 2. Men and women aged 18 to 80 years old.
- 3. Diagnosed with diabetic lower limb ulcer.
- 4. Ulcer duration> 1 month of wagner grade Ⅱ, Ⅲ subjects.
- 5. An ulcer area ≤100 cm² or of linear dimension ≤ 10 cm.
Who cannot join
- 1. Diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent.
- 2. Pregnant or lactating women.
- 3. Wagner grade Ⅰ, Ⅳ, Ⅴ subjects.
- 4. Patients with a peripheral vascular disease require immediate revascularization, and/or an ankle brachial systolic blood pressure (SBP) index<0.5 in the infected limb.
- 5. Patients with inappropriate health to participate as determined by the principal investigators.
- 6. Patients in the hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases of the active period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qingfeng Cheng, PhD, 086-23-89011510, cqf19760516@163.com
About this study
Official title: Efficacy and Safety of Methylene Blue -Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer : a Randomized Controlled Study
The investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism.
Read the detailed description
OBJECTIVE- Infection is associated with poor healing of diabetic lower limb ulcer. Diabetic lower limb ulcer are often lower extremity vascular stenosis or occlusion, poor blood supply, making local ulcer local antibacterial drugs difficult to effectively reach and distribution, resulting in systemic antibacterial efficacy is limited, and easy to induce bacterial resistance at the same time . In recent years, the incidence of clinical multidrug-resistant bacteria increased, increasing the difficulty and cost of treatment.
The current study attempts to identify whether the photodynamic therapy (PDT) would kill the surface of ulcer bacteria and promote ulcer healing, and explore the mechanism of methylene blue-mediated photodynamic therapy for diabetic lower limb ulcer RESEARCH DESIGN AND METHODS-This study evaluated six clinical indicators： diabetic foot ulcer area reduction rate, inflammation control rate, Local bacterial load, the dose and use time of antibiotics, adverse reaction rate, bacterial biofilm,local neutrophil extracellular traps. The efficacy and safety of PDT could be confirmed if the clinical indicators of PDT group is better than the control group. In this study, three methods were used to investigate the mechanism of -methylene blue mediated photodynamic therapy for diabetic lower limb ulcer: a comparison of the bacterial load, bacterial biofilm,local neutrophil extracellular traps of the ulcer immediately pre-treatment and immediately,1-week ,2 week,1 momth post-treatment ; EXPECTED RESULTS-The investigators will expect that methylene blue-mediated photodynamic therapy could kill bacteria on the surface of diabetic lower limb ulcer and accelerate wound healing.
- Conditions
- Diabetic Extremity Lower Ulcers
- Being tested
- methylene blue, Photon therapy instrument
- Keywords
- methylene blue, Photodynamics Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylene blueCombination product
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
Photon therapy instrumentCombination product
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy | Experimental | The photosensitizer, methylene blue, is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photodynamic therapy is applied once a day for a total of seven times. Receives: Combination Product: methylene blue |
| Photon therapy | Active comparator | The placebo is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photon therapy is applied once a day for a total of seven times. Receives: Combination Product: Photon therapy instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline （Ulcer area）in the diabetic lower limb ulcer at day 7
Changes of ulcer area before and after treatment
Measured: Baseline and day 7
Change from baseline (immediately before the first treatment) in the bacterial load of the ulcer at one hour (immediately after the first treatment)
Changes of local bacterial load before and after treatment
Measured: Baseline and (immediately after the first treatment)，day 7,14,21,28
Change from baseline(bacterial biofilm）
Changes of local bacterial biofilm before and after treatment
Measured: Baseline and day 7,14,21,28
Secondary outcomes (5)
The dose of antibiotics
Dosage of antibiotics during treatment
Measured: 7 days during treatment
The time of antibiotics
Antibiotic use time during treatment
Measured: 7 days during treatment
Adverse events
including pain,redness, and swelling
Measured: 7 days during treatment
A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment
Fluorescence intensity and area of local NET
Measured: Baseline and day 7,14,21,28
Inflammation control rate
Duration of inflammation
Measured: 7 days during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start29 Apr 2019 (estimated)
- Primary completion29 Apr 2020 (estimated)
- Study completion29 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Extremity Lower UlcersStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Qing-feng, Chongqing Medical University
- Investigators
- Qingfeng Cheng, PhD, Principal investigator, the First Affiliated Hospital, Chongqing Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222544
- Sponsor's protocol ID
- PDT2017
- Status last verified
- Apr 2019
- First submitted
- 5 Jul 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tardivo JP, Adami F, Correa JA, Pinhal MA, Baptista MS. A clinical trial testing the efficacy of PDT in preventing amputation in diabetic patients. Photodiagnosis Photodyn Ther. 2014 Sep;11(3):342-50. doi: 10.1016/j.pdpdt.2014.04.007. Epub 2014 May 9.
PubMed 24814697Lei X, Liu B, Huang Z, Wu J. A clinical study of photodynamic therapy for chronic skin ulcers in lower limbs infected with Pseudomonas aeruginosa. Arch Dermatol Res. 2015 Jan;307(1):49-55. doi: 10.1007/s00403-014-1520-4. Epub 2014 Nov 20.
PubMed 25410983Detty MR, Gibson SL, Wagner SJ. Current clinical and preclinical photosensitizers for use in photodynamic therapy. J Med Chem. 2004 Jul 29;47(16):3897-915. doi: 10.1021/jm040074b. No abstract available.
PubMed 15267226Giraudeau C, Moussaron A, Stallivieri A, Mordon S, Frochot C. Indocyanine green: photosensitizer or chromophore? Still a debate. Curr Med Chem. 2014;21(16):1871-97. doi: 10.2174/0929867321666131218095802.
PubMed 24350844Nicolau DP, Stein GE. Therapeutic options for diabetic foot infections: a review with an emphasis on tissue penetration characteristics. J Am Podiatr Med Assoc. 2010 Jan-Feb;100(1):52-63. doi: 10.7547/1000052.
PubMed 20093545
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Methylene Blue -Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03222544
- Acronym / sponsor ID
- PDT2017
- Conditions
- Diabetic Extremity Lower Ulcers
- Keywords
- methylene blue, Photodynamics Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (estimated)
- Primary completion
- 29 Apr 2020 (estimated)
- Study completion
- 29 Jun 2020 (estimated)
- First posted
- 19 Jul 2017 (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.
The investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism.
Detailed description
OBJECTIVE- Infection is associated with poor healing of diabetic lower limb ulcer. Diabetic lower limb ulcer are often lower extremity vascular stenosis or occlusion, poor blood supply, making local ulcer local antibacterial drugs difficult to effectively reach and distribution, resulting in systemic antibacterial efficacy is limited, and easy to induce bacterial resistance at the same time . In recent years, the incidence of clinical multidrug-resistant bacteria increased, increasing the difficulty and cost of treatment.
The current study attempts to identify whether the photodynamic therapy (PDT) would kill the surface of ulcer bacteria and promote ulcer healing, and explore the mechanism of methylene blue-mediated photodynamic therapy for diabetic lower limb ulcer RESEARCH DESIGN AND METHODS-This study evaluated six clinical indicators： diabetic foot ulcer area reduction rate, inflammation control rate, Local bacterial load, the dose and use time of antibiotics, adverse reaction rate, bacterial biofilm,local neutrophil extracellular traps. The efficacy and safety of PDT could be confirmed if the clinical indicators of PDT group is better than the control group. In this study, three methods were used to investigate the mechanism of -methylene blue mediated photodynamic therapy for diabetic lower limb ulcer: a comparison of the bacterial load, bacterial biofilm,local neutrophil extracellular traps of the ulcer immediately pre-treatment and immediately,1-week ,2 week,1 momth post-treatment ; EXPECTED RESULTS-The investigators will expect that methylene blue-mediated photodynamic therapy could kill bacteria on the surface of diabetic lower limb ulcer and accelerate wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Therapy | Experimental | Combination Product: methylene blueThe photosensitizer, methylene blue, is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photodynamic therapy is applied once a day for a total of seven times. |
| Photon therapy | Active comparator | Combination Product: Photon therapy instrumentThe placebo is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photon therapy is applied once a day for a total of seven times. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Understand the whole test process, voluntary and signed informed consent form.
- 2. Men and women aged 18 to 80 years old.
- 3. Diagnosed with diabetic lower limb ulcer.
- 4. Ulcer duration> 1 month of wagner grade Ⅱ, Ⅲ subjects.
- 5. An ulcer area ≤100 cm² or of linear dimension ≤ 10 cm.
Key exclusion criteria (6 listed)
- 1. Diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent.
- 2. Pregnant or lactating women.
- 3. Wagner grade Ⅰ, Ⅳ, Ⅴ subjects.
- 4. Patients with a peripheral vascular disease require immediate revascularization, and/or an ankle brachial systolic blood pressure (SBP) index<0.5 in the infected limb.
- 5. Patients with inappropriate health to participate as determined by the principal investigators.
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 |
|---|---|---|
| methylene blueContinue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand | Combination product | Photodynamic Therapy |
| Photon therapy instrumentContinue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand | Combination product | Photon therapy |
Primary outcome
Change from baseline （Ulcer area）in the diabetic lower limb ulcer at day 7
Time frame: Baseline and day 7
Changes of ulcer area before and after treatment
Change from baseline (immediately before the first treatment) in the bacterial load of the ulcer at one hour (immediately after the first treatment)
Time frame: Baseline and (immediately after the first treatment)，day 7,14,21,28
Changes of local bacterial load before and after treatment
Change from baseline(bacterial biofilm）
Time frame: Baseline and day 7,14,21,28
Changes of local bacterial biofilm before and after treatment
5 secondary outcomes
The dose of antibiotics
Time frame: 7 days during treatment
The time of antibiotics
Time frame: 7 days during treatment
Adverse events
Time frame: 7 days during treatment
A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment
Time frame: Baseline and day 7,14,21,28
Inflammation control rate
Time frame: 7 days during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Results publication: PubMed 24814697Tardivo JP, Adami F, Correa JA, Pinhal MA, Baptista MS. A clinical trial testing the efficacy of PDT in preventing amputation in diabetic patients. Photodiagnosis Photodyn Ther. 2014 Sep;11(3):342-50. doi: 10.1016/j.pdpdt.2014.04.007. Epub 2014 May 9.
- Results publication: PubMed 25410983Lei X, Liu B, Huang Z, Wu J. A clinical study of photodynamic therapy for chronic skin ulcers in lower limbs infected with Pseudomonas aeruginosa. Arch Dermatol Res. 2015 Jan;307(1):49-55. doi: 10.1007/s00403-014-1520-4. Epub 2014 Nov 20.
- Results publication: PubMed 15267226Detty MR, Gibson SL, Wagner SJ. Current clinical and preclinical photosensitizers for use in photodynamic therapy. J Med Chem. 2004 Jul 29;47(16):3897-915. doi: 10.1021/jm040074b. No abstract available.
- Results publication: PubMed 24350844Giraudeau C, Moussaron A, Stallivieri A, Mordon S, Frochot C. Indocyanine green: photosensitizer or chromophore? Still a debate. Curr Med Chem. 2014;21(16):1871-97. doi: 10.2174/0929867321666131218095802.
- Results publication: PubMed 20093545Nicolau DP, Stein GE. Therapeutic options for diabetic foot infections: a review with an emphasis on tissue penetration characteristics. J Am Podiatr Med Assoc. 2010 Jan-Feb;100(1):52-63. doi: 10.7547/1000052.
- Individual participant dataSharing planned: No
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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.
Qingfeng Cheng, PhD principal investigator
the First Affiliated Hospital, Chongqing Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylene blue and Photon therapy instrument in people with Diabetic Extremity Lower Ulcers, run by Chongqing Medical University 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 5 inclusion and 6 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 23 Apr 2019. 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 Qingfeng Cheng, PhD (086-23-89011510, cqf19760516@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline （Ulcer area）in the diabetic lower limb ulcer at day 7 (time frame: Baseline and day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222544, which also lists 5 linked publications.
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 23 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.