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

C

Corporacion Parc Tauli

Status

Completed

Conditions

Diabetic Foot Ulcer Neuropathic
Diabetic Foot Ulcer

Treatments

Device: Piscean collagen dressing
Device: Saline infused dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT05324930
CDDF37628

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

180 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
After conventional therapy consisting of debridement, infection control and offloading, patients received a saline-moistened gauze dressing (control group) for wound care.
Treatment:
Device: Saline infused dressing
Experimental group
Experimental group
Description:
After conventional therapy consisting of debridement, infection control and offloading, patients received the piscean collagen dressing (the study group) for wound care.
Treatment:
Device: Piscean collagen dressing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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