NCT03222544

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

July 5, 2017

Last Update Submit

April 22, 2019

Conditions

Diabetic Extremity Lower Ulcers

Keywords

methylene bluePhotodynamics Therapy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Change from baseline(bacterial biofilm）

    Changes of local bacterial biofilm before and after treatment

    Baseline and day 7,14,21,28

Secondary Outcomes (5)

  • The dose of antibiotics

    7 days during treatment

  • The time of antibiotics

    7 days during treatment

  • Adverse events

    7 days during treatment

  • A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment

    Baseline and day 7,14,21,28

  • Inflammation control rate

    7 days during treatment

Study Arms (2)

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.

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.

Combination Product: Photon therapy instrument

Interventions

methylene blueCOMBINATION_PRODUCT

Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand

Photodynamic Therapy
Photon therapy instrumentCOMBINATION_PRODUCT

Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand

Photon therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Understand the whole test process, voluntary and signed informed consent form.
  • \. Men and women aged 18 to 80 years old.
  • \. Diagnosed with diabetic lower limb ulcer.
  • \. Ulcer duration\> 1 month of wagner grade Ⅱ, Ⅲ subjects.
  • \. An ulcer area ≤100 cm² or of linear dimension ≤ 10 cm.

You may not qualify if:

  • \. Diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent.
  • \. Pregnant or lactating women.
  • \. Wagner grade Ⅰ, Ⅳ, Ⅴ subjects.
  • \. 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.
  • \. Patients with inappropriate health to participate as determined by the principal investigators.
  • \. Patients in the hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases of the active period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 24814697RESULT

  • 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.

    PMID: 25410983RESULT

  • 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. doi: 10.1021/jm040074b. No abstract available.

    PMID: 15267226RESULT

  • 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. doi: 10.2174/0929867321666131218095802.

    PMID: 24350844RESULT

  • 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. doi: 10.7547/1000052.

    PMID: 20093545RESULT

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Qingfeng Cheng, PhD

    the First Affiliated Hospital, Chongqing Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingfeng Cheng, PhD

CONTACT

086-23-89011510cqf19760516@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 19, 2017

Study Start

April 29, 2019

Primary Completion

April 29, 2020

Study Completion

June 29, 2020

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)