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

NCT ID: NCT03380403

Last Updated: 2017-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2012-01-01

Brief Summary

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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

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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.

Conditions

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Diabetic Foot Infection Osteomyelitis Photo Antimicrobial Chemotherapy

Keywords

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diabetic foot Osteomyelitis PACT PDT Singlet oxygen antimicrobial diabetes Wagner scale

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

non-randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDT

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

Group Type ACTIVE_COMPARATOR

PDT

Intervention Type RADIATION

clinical treatment of infected diabetic foot

Ciprofloxacin

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

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type OTHER

antibiotics and or surgical debridment

Interventions

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PDT

clinical treatment of infected diabetic foot

Intervention Type RADIATION

Ciprofloxacin

antibiotics and or surgical debridment

Intervention Type OTHER

Other Intervention Names

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photoantimicrobial chemotherapy Conventional treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Responsible Party

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João Paulo Tardivo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 27884621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26281044 (View on PubMed)

Abrahamse H, Hamblin MR. New photosensitizers for photodynamic therapy. Biochem J. 2016 Feb 15;473(4):347-64. doi: 10.1042/BJ20150942.

Reference Type RESULT
PMID: 26862179 (View on PubMed)

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.

Reference Type RESULT
PMID: 26160556 (View on PubMed)

Other Identifiers

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Faculdade de medicina do ABC

Identifier Type: -

Identifier Source: org_study_id