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

NCT ID: NCT05324930

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-09-01

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.

Conditions

Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

After conventional therapy consisting of debridement, infection control and offloading, patients received a saline-moistened gauze dressing (control group) for wound care.

Group Type: PLACEBO_COMPARATOR

Saline infused dressing

Intervention Type: DEVICE

Saline infused dressing

Experimental group

After conventional therapy consisting of debridement, infection control and offloading, patients received the piscean collagen dressing (the study group) for wound care.

Group Type: EXPERIMENTAL

Piscean collagen dressing

Intervention Type: DEVICE

Piscean collagen dressing

Interventions

Piscean collagen dressing

Piscean collagen dressing

Intervention Type: DEVICE

Saline infused dressing

Saline infused dressing

Intervention Type: DEVICE

Other Intervention Names

Dressing

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Dr Zainab Khan

Chief Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zainab Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Punjab Care hospital

Locations

Zainab Khan

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

CDDF37628

Identifier Type: -

Identifier Source: org_study_id