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A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients

Primary Purpose

Diabetic Foot Infection, Osteomyelitis, Photo Antimicrobial Chemotherapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDT
Ciprofloxacin
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Infection focused on measuring diabetic foot, Osteomyelitis, PACT, PDT, Singlet oxygen, antimicrobial, diabetes, Wagner scale

Eligibility Criteria

18 Years - 83 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age > 18 years old
  • diabetes
  • diabetic foot
  • Wagner grade III

Exclusion Criteria:

  • age < 18 years old
  • non-diabetic
  • Wagner IV and V
  • ischemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    PDT

    Ciprofloxacin

    Arm Description

    Methylene blue and Photon Irradiation , every each week, until total ulcer healing.

    Diabetic foot patients were treated on conventional way, using antibiotics and surgery.

    Outcomes

    Primary Outcome Measures

    Infection control
    blood count - leucocytes for infection

    Secondary Outcome Measures

    Osteomyelitis evaluation
    Radiographs were used when patients presented osteomyelitis

    Full Information

    First Posted
    November 24, 2017
    Last Updated
    December 26, 2017
    Sponsor
    Faculdade de Medicina do ABC
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03380403
    Brief Title
    A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
    Official Title
    A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    January 1, 2012 (Actual)
    Study Completion Date
    January 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Faculdade de Medicina do ABC
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.
    Detailed Description
    Patients with infected diabetic foot were grouped according to the Wagner system for classifying foot lesions. All patients presented Wagner Grade 3 classification, with osteomyelitis in one or more toes. The study included only patients who had circulatory viability. For PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that, light irradiation was performed with optical fibers or led device above the wound. PDT treatment always in outpatients, once or twice a week.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Infection, Osteomyelitis, Photo Antimicrobial Chemotherapy
    Keywords
    diabetic foot, Osteomyelitis, PACT, PDT, Singlet oxygen, antimicrobial, diabetes, Wagner scale

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    non-randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PDT
    Arm Type
    Active Comparator
    Arm Description
    Methylene blue and Photon Irradiation , every each week, until total ulcer healing.
    Arm Title
    Ciprofloxacin
    Arm Type
    Active Comparator
    Arm Description
    Diabetic foot patients were treated on conventional way, using antibiotics and surgery.
    Intervention Type
    Radiation
    Intervention Name(s)
    PDT
    Other Intervention Name(s)
    photoantimicrobial chemotherapy
    Intervention Description
    clinical treatment of infected diabetic foot
    Intervention Type
    Other
    Intervention Name(s)
    Ciprofloxacin
    Other Intervention Name(s)
    Conventional treatment
    Intervention Description
    antibiotics and or surgical debridment
    Primary Outcome Measure Information:
    Title
    Infection control
    Description
    blood count - leucocytes for infection
    Time Frame
    every month until three months , when blood count- leucocytes reach the standard value.
    Secondary Outcome Measure Information:
    Title
    Osteomyelitis evaluation
    Description
    Radiographs were used when patients presented osteomyelitis
    Time Frame
    once a month, until three months, when X-ray shows bone reconstitution .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    83 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age > 18 years old diabetes diabetic foot Wagner grade III Exclusion Criteria: age < 18 years old non-diabetic Wagner IV and V ischemia

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27884621
    Citation
    Wainwright M, Maisch T, Nonell S, Plaetzer K, Almeida A, Tegos GP, Hamblin MR. Photoantimicrobials-are we afraid of the light? Lancet Infect Dis. 2017 Feb;17(2):e49-e55. doi: 10.1016/S1473-3099(16)30268-7. Epub 2016 Nov 22.
    Results Reference
    background
    PubMed Identifier
    26281044
    Citation
    Tardivo JP, Baptista MS, Correa JA, Adami F, Pinhal MA. Development of the Tardivo Algorithm to Predict Amputation Risk of Diabetic Foot. PLoS One. 2015 Aug 17;10(8):e0135707. doi: 10.1371/journal.pone.0135707. eCollection 2015.
    Results Reference
    background
    PubMed Identifier
    26862179
    Citation
    Abrahamse H, Hamblin MR. New photosensitizers for photodynamic therapy. Biochem J. 2016 Feb 15;473(4):347-64. doi: 10.1042/BJ20150942.
    Results Reference
    result
    PubMed Identifier
    26160556
    Citation
    Sahu K, Sharma M, Dube A, Gupta PK. Topical antimicrobial photodynamic therapy improves angiogenesis in wounds of diabetic mice. Lasers Med Sci. 2015 Sep;30(7):1923-9. doi: 10.1007/s10103-015-1784-8. Epub 2015 Jul 10.
    Results Reference
    result

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    A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients

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