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Bacteria-produced dressing for treating wounds in diabetic patients

POLYTISSUE film associated with bacterial cellulose hydrogel for the treatment of venous ulcers in diabetic patients - POLYTISSUE-BC POLYTISSUE film associated with bacterial cellulose hydrogel for the treatment of venous ulcers in diabetic patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-2q63v4h
Enrollment
Unknown
Registered
2025-11-14
Start date
2026-01-20
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Diabetes Mellitus

Interventions

Simple prospective randomized intervention study randomization will be performed using the Research Randomizer software version four point zero available at www point randomizer point org due to the c

Sponsors

Universidade Federal de Alagoas (UFAL)
Lead Sponsor
Polisa Biopolímero para Saúde
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults with a diagnosis of non-infected venous ulcer in the granulation phase; with or without diabetes.

Exclusion criteria

Exclusion criteria: Pregnant women; allergy to the compound; venous ulcers resulting from trauma or any other non-chronic superficial skin lesions; significant systemic infection; cognitive deficit that prevents participation in the research; voluntary request to withdraw from the research.

Design outcomes

Primary

MeasureTime frame
It is expected to find the epithelialization process as the primary outcome.

Secondary

MeasureTime frame
It is expected to observe the healing time with the use of POLYTISSUE® film and gel as a secondary outcome.

Countries

Brazil

Contacts

Public ContactJaiurte da Silva

Universidade Federal de Alagoas, campus Arapiraca

jaiurte.silva@arapiraca.ufal.br+55 (82) 34821800

Outcome results

None listed

Source: REBEC (via WHO ICTRP)