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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer
• Interventions: Device: Saline infused dressing; Device: Piscean collagen dressing

• Registration Number: NCT05324930
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Study Timeline

• Study Start: 2021-12-02
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-09
• Study First Posted: 2022-04-13
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• patients with neuropathic DFUs at Grades I or II for a period of at least 12 weeks, based on the Wagner classification;
• be able to understand simple instructions and provided voluntary, signed informed consent.

Exclusion Criteria

• active infection which might lead to hospitalisation, gangrene,
• systemic inflammatory or autoimmune disease
• renal failure
• presence of ischaemia or osteomyelitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline infused dressing	After conventional therapy consisting of debridement, infection control and offloading, patients received a saline-moistened gauze dressing (control group) for wound care.
Experimental group	Piscean collagen dressing	After conventional therapy consisting of debridement, infection control and offloading, patients received the piscean collagen dressing (the study group) for wound care.

Primary Outcome Measures

Name	Time	Method
Change in DFU size	3 months	change in DFU size using the manual planimetric method

Secondary Outcome Measures

Name	Time	Method
Complete wound healing	3 months	Complete wound healing using three-dimensional wound measurement software

Trial Locations

Locations (1)

Zainab Khan; 🇵🇰 Lahore, Punjab, Pakistan