NCT05324930

Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients

Evaluating the Effectiveness of Collagen Matrix Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients: a Randomised Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU. This is a double-blinded, randomised clinical trial.

Detailed description

Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU. This is a double-blinded, randomised clinical trial. After conventional therapy consisting of debridement, infection control and offloading, patients were randomly allocated to receive either a piscean matrix dressing (the study group) or a saline-moistened gauze dressing (control group) for wound care. The reduction in DFU size and the number of patients with complete healing were measured throughout the treatment and in follow-up.

Conditions

• Diabetic Foot Ulcer Neuropathic
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Piscean collagen dressing	Piscean collagen dressing
DEVICE	Saline infused dressing	Saline infused dressing

Timeline

• Start date: 2021-12-02
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-04-13
• Last updated: 2022-11-01

Locations

1 site across 1 country: Pakistan