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Use of Latex Membrane associated with a Phototherapy equipment in the resolution of Infected Diabetic Feet

Development of a Latex Membrane associated with a Portable Photodynamic Therapy transducer for use in Diabetic Foot infected wounds

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-58vjpf6
Enrollment
Unknown
Registered
2023-03-16
Start date
2022-08-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Interventions

This is a three-arm, double-blind, randomized controlled clinical trial. Experimental groups: Group 1: 20 men and/or women will be treated with a cluster of LEDs associated with membrane with annatto
E02.186.500

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade de Brasília
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diabetic volunteers; both genders; age between 18 and 60 years; diagnosis of type 1 or type 2 diabetes; have infected plantar ulcers

Exclusion criteria

Exclusion criteria: patients with peripheral vascular disease; previous use of local or systemic antibiotics or corticosteroids up to five days before treatment; lactating and pregnant women

Design outcomes

Primary

MeasureTime frame
It is expected to observe an increase in the healing of infected diabetic wounds evaluated by healing rate. Data collected before the intervention and at the end of the intervention protocol.—

Secondary

MeasureTime frame
It is expected to find an improvement in functionality, assessed by the WHODAS 2.0 instrument. Data collected before the intervention and three months after the end of the intervention protocol—

Countries

Brazil

Contacts

Public ContactJosé Tatmatsu Rocha

Universidade Federal do Ceará

tatmatsu@ufc.br+55 (85) 3366 8091

Outcome results

None listed

Source: REBEC (via WHO ICTRP)