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Completed

NCT Number: NCT05324930

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

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.

Completed

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zainab Khan

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piscean collagen dressing

Device

Piscean collagen dressing

Other names: Dressing

Saline infused dressing

Device

Saline infused dressing

Primary outcomes

  1. Change in DFU size

    Time frame: 3 months

    change in DFU size using the manual planimetric method

Secondary outcomes

  1. Complete wound healing

    Time frame: 3 months

    Complete wound healing using three-dimensional wound measurement software

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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