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Development of a diaphragm footbed for the treatment of wounds on diabetic feet based on a membrane with natural medicine

Development of a Diabetic Foot Insole Derived from Natural Latex with Tissue Neoform Induction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5rd2hx
Enrollment
Unknown
Registered
2018-12-17
Start date
2013-08-01
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

Patient diabetic patients presenting diabetic foot ulcer of neuropathic and / or vascular origin with or without clinical signs of infection

Interventions

Control group of 4 patients: conventional treatment consisting of debridement of devitalized tissues, hygienization with saline solution 0.9%, followed by the placement of a dressing with foam with si
75 days according to wound severity and complete healing Experimental group: 6 diabetic patients and experimental treatment (home) done after previous cleaning of the ulcer with 0.9% saline solution
phototherapy for approximately 35 minutes and use of the healing insole for a minimum period of approximately 10 hours
exchanges every 10 days or once a week
Device
E02.774

Sponsors

Universidade de Brasilia
Lead Sponsor
Universidade de Brasilia
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subject of the Regional Hospital of Taguatinga; of both sexes; age from 18 to 75 years; presenting diabetic foot ulcer of neuropathic and / or vascular origin with or without clinical signs of infection; who agree to participate and sign the TCLE (Informed Consent Form); with capacity to provide information about the tests and to collaborate with the project.

Exclusion criteria

Exclusion criteria: Pregnant; patient who drinks alcohol and / or drugs; evidence of osteomyelitis or gangrene somewhere on the affected extremity; topical application at the wound site after the start of the study that were not adopted in this protocol; present discomfort during the treatment application; patients who miss three consecutive times.

Design outcomes

Primary

MeasureTime frame
The objective of this study was to evaluate the healing of neuropathic and ischemic ulcers caused by diabetes mellitus. The analysis was made through the percentage of contraction of the ulcers measured through the initial areas and at the end of the treatments;An average healing process index of 82.8% was observed in the Experimental Group and 59.1% in the Control Group

Secondary

MeasureTime frame
No secundary outcomes were expected

Countries

Brazil

Contacts

Public ContactSuelia Rosa

Universidade de Brasilia

rodrigues.suelia@gmail.com+55 (61) 3107-8901

Outcome results

None listed

Source: REBEC (via WHO ICTRP)