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

Sponsor
Faculdade de Medicina do ABC (Other)
Overall Status
Completed
CT.gov ID
NCT03380403
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
34
Enrollment
2
Arms
24
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: PDT
  • Other: Ciprofloxacin
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
non-randomized clinical trialnon-randomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PDT

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

Radiation: PDT
clinical treatment of infected diabetic foot
Other Names:
  • photoantimicrobial chemotherapy

    		•
    Active Comparator: Ciprofloxacin

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

    Other: Ciprofloxacin
    antibiotics and or surgical debridment
    Other Names:
  • Conventional treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Infection control [every month until three months , when blood count- leucocytes reach the standard value.]

      blood count - leucocytes for infection

    Secondary Outcome Measures

    1. Osteomyelitis evaluation [once a month, until three months, when X-ray shows bone reconstitution .]

      Radiographs were used when patients presented osteomyelitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 83 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Faculdade de Medicina do ABC
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    João Paulo Tardivo, Principal Investigator, Faculdade de Medicina do ABC
    ClinicalTrials.gov Identifier:
    NCT03380403
    Other Study ID Numbers:
    • Faculdade de medicina do ABC
    First Posted:
    Dec 21, 2017
    Last Update Posted:
    Dec 28, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by João Paulo Tardivo, Principal Investigator, Faculdade de Medicina do ABC
    diabetic foot
    Osteomyelitis
    PACT
    PDT
    Singlet oxygen
    antimicrobial
    diabetes
    Wagner scale
    Additional relevant MeSH terms:
    Osteomyelitis
    Diabetic Foot
    Ciprofloxacin

    Study Results

    No Results Posted as of Dec 28, 2017