Clinical Study of Methylene Blue - Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer

Diabetic Extremity Lower Ulcers Clinical Trial

Official title:

Efficacy and Safety of Methylene Blue -Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer : a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222544
• Other study ID #: PDT2017
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: June 29, 2020

Study information

• Verified date: April 2019
• Source: Chongqing Medical University
• Contact: Qingfeng Cheng, PhD
• Phone: 086-23-89011510
• Email: cqf19760516[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 ?, ? subjects.

• 5. An ulcer area =100 cm² or of linear dimension = 10 cm.

Exclusion Criteria:

• 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 ?, ?, ? 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.

Related Conditions & MeSH terms

• Diabetic Extremity Lower Ulcers
• Ulcer

Intervention

Combination Product:
• methylene blue
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
• Photon therapy instrument
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Detty 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. Review. — View Citation

Giraudeau 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. Review. — View Citation

Lei 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. — View Citation

Nicolau 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (Ulcer area)in the diabetic lower limb ulcer at day 7	Changes of ulcer area before and after treatment	Baseline and day 7
Primary	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	Baseline and (immediately after the first treatment),day 7,14,21,28
Primary	Change from baseline(bacterial biofilm)	Changes of local bacterial biofilm before and after treatment	Baseline and day 7,14,21,28
Secondary	The dose of antibiotics	Dosage of antibiotics during treatment	7 days during treatment
Secondary	The time of antibiotics	Antibiotic use time during treatment	7 days during treatment
Secondary	Adverse events	including pain,redness, and swelling	7 days during treatment
Secondary	A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment	Fluorescence intensity and area of local NET	Baseline and day 7,14,21,28
Secondary	Inflammation control rate	Duration of inflammation	7 days during treatment