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CompletedNCT05324930Updated Nov 1, 2022

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

An interventional study of Piscean collagen dressing and Saline infused dressing in Diabetic Foot Ulcer Neuropathic and Diabetic Foot Ulcer, sponsored by Corporacion Parc Tauli. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcer Neuropathic
  • Diabetic Foot Ulcer
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 180 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • active infection which might lead to hospitalisation, gangrene,
  • systemic inflammatory or autoimmune disease
  • renal failure
  • presence of ischaemia or osteomyelitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DevicePiscean collagen dressing

    Piscean collagen dressing

    Also known as: Dressing

  • DeviceSaline infused dressing

    Saline infused dressing

06

What researchers measure

Primary outcomes

  1. Change in DFU size

    change in DFU size using the manual planimetric method

    Time frame: 3 months

Secondary outcomes

  1. Complete wound healing

    Complete wound healing using three-dimensional wound measurement software

    Time frame: 3 months

07

Study locations

1 site
  • Zainab Khan
    Lahore, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be provided upon reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05324930
Lead sponsor
Corporacion Parc Tauli
Responsible party
Dr Zainab Khan (Chief Resident, Corporacion Parc Tauli) — Principal investigator
First posted
Apr 13, 2022
Start date
Dec 2, 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022
Last update
Nov 1, 2022

Study contacts

Zainab Khan, MD
principal investigator · Punjab Care hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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