Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
Conditions
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.
Interventions
DEVICEPiscean collagen dressing
Piscean collagen dressing
DEVICESaline infused dressing
Saline infused dressing
Sponsors
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Double blinded, randomized control trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DFU size | 3 months | change in DFU size using the manual planimetric method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete wound healing | 3 months | Complete wound healing using three-dimensional wound measurement software |
Countries
Pakistan
Outcome results
None listed