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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piscean collagen dressing | Device | Piscean collagen dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DFU size | change in DFU size using the manual planimetric method | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete wound healing | Complete wound healing using three-dimensional wound measurement software | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zainab Khan, MD | Punjab Care hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zainab Khan | Lahore | Punjab Province | Pakistan |
Data can be provided upon reasonable request
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Double blinded, randomized control trial
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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.
| Saline infused dressing | Device | Saline infused dressing |
|
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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