NCT03380403

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

November 24, 2017

Last Update Submit

December 26, 2017

Conditions

Diabetic Foot InfectionOsteomyelitisPhoto Antimicrobial Chemotherapy

Keywords

diabetic footOsteomyelitisPACTPDTSinglet oxygenantimicrobialdiabetesWagner scale

Outcome Measures

Primary Outcomes (1)

  • Infection control

    blood count - leucocytes for infection

    every month until three months , when blood count- leucocytes reach the standard value.

Secondary Outcomes (1)

  • Osteomyelitis evaluation

    once a month, until three months, when X-ray shows bone reconstitution .

Study Arms (2)

PDT

ACTIVE COMPARATOR

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

Radiation: PDT

Ciprofloxacin

ACTIVE COMPARATOR

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

Other: Ciprofloxacin

Interventions

PDTRADIATION

clinical treatment of infected diabetic foot

Also known as: photoantimicrobial chemotherapy
PDT
CiprofloxacinOTHER

antibiotics and or surgical debridment

Also known as: Conventional treatment
Ciprofloxacin

Eligibility Criteria

Age18 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 27884621BACKGROUND

  • 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.

    PMID: 26281044BACKGROUND

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

    PMID: 26862179RESULT

  • 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.

    PMID: 26160556RESULT

MeSH Terms

Conditions

OsteomyelitisDiabetic FootDiabetes Mellitus

Interventions

1-phenyl-3,3-dimethyltriazeneCiprofloxacin

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: non-randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 21, 2017

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 28, 2017

Record last verified: 2017-12