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NCT05324930 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05324930
Other study ID # CDDF37628
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2, 2021
Est. completion date September 1, 2022

Study information
Verified date October 2022
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Piscean collagen dressing
Piscean collagen dressing
• Saline infused dressing
Saline infused dressing

Locations
Country Name City State
Pakistan Zainab Khan Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in DFU size change in DFU size using the manual planimetric method 3 months
Secondary Complete wound healing Complete wound healing using three-dimensional wound measurement software 3 months
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