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

NCT05324930 | Completed

• 1 other identifier: CDDF37628
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Change in DFU size

  change in DFU size using the manual planimetric method

  3 months

Secondary Outcomes (1)

• Complete wound healing

  3 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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 group

EXPERIMENTAL

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

Piscean collagen dressing DEVICE

Piscean collagen dressing

Also known as: Dressing

Experimental group

Saline infused dressing DEVICE

Saline infused dressing

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Zainab Khan

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Zainab Khan, MD

  Punjab Care hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident

Model Details: Double blinded, randomized control trial

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 13, 2022
• Study Start: December 2, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)