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

December 26, 2017 updated by: João Paulo Tardivo, Faculdade de Medicina do ABC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection control
Time Frame: every month until three months , when blood count- leucocytes reach the standard value.
blood count - leucocytes for infection
every month until three months , when blood count- leucocytes reach the standard value.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteomyelitis evaluation
Time Frame: once a month, until three months, when X-ray shows bone reconstitution .
Radiographs were used when patients presented osteomyelitis
once a month, until three months, when X-ray shows bone reconstitution .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 26, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faculdade de medicina do ABC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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