Evaluating the Effectiveness of Collagen Matrix Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients: a Randomised Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer Neuropathic
- Sponsor
- Corporacion Parc Tauli
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change in DFU size
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Dr Zainab Khan
Chief Resident
Corporacion Parc Tauli
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in DFU size
Time Frame: 3 months
change in DFU size using the manual planimetric method
Secondary Outcomes
- Complete wound healing(3 months)