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

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324930
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
4.9
Anticipated Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Piscean collagen dressing
  • Device: Saline infused dressing
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blinded, randomized control trialDouble blinded, randomized control trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Patients were randomized, all boxes of dressings were opened and healthcare professional applying the dressing and assessing the wound was unaware of what treatment is being given.
Primary Purpose:
Treatment
Official Title:
Evaluating the Effectiveness of Collagen Matrix Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients: a Randomised Control Trial
Actual Study Start Date :
Dec 2, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group

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

Device: Saline infused dressing
Saline infused dressing
Experimental: Experimental group

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

Device: Piscean collagen dressing
Piscean collagen dressing
Other Names:
  • Dressing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in DFU size [3 months]

      change in DFU size using the manual planimetric method

    Secondary Outcome Measures

    1. Complete wound healing [3 months]

      Complete wound healing using three-dimensional wound measurement software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zainab Khan Lahore Punjab Pakistan

    Sponsors and Collaborators

    • Corporacion Parc Tauli

    Investigators

    • Principal Investigator: Zainab Khan, MD, Punjab Care hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Zainab Khan, Chief Resident, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT05324930
    Other Study ID Numbers:
    • CDDF37628
    First Posted:
    Apr 13, 2022
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Diabetic Foot
    Foot Ulcer
    Ulcer

    Study Results

    No Results Posted as of Apr 13, 2022