Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients
Primary Purpose
Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Piscean collagen dressing
Saline infused dressing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer Neuropathic
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
Sites / Locations
- Zainab Khan
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
After conventional therapy consisting of debridement, infection control and offloading, patients received a saline-moistened gauze dressing (control group) for wound care.
After conventional therapy consisting of debridement, infection control and offloading, patients received the piscean collagen dressing (the study group) for wound care.
Outcomes
Primary Outcome Measures
Change in DFU size
change in DFU size using the manual planimetric method
Secondary Outcome Measures
Complete wound healing
Complete wound healing using three-dimensional wound measurement software
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05324930
Brief Title
Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients
Official Title
Evaluating the Effectiveness of Collagen Matrix Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients: a Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, randomized control trial
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
After conventional therapy consisting of debridement, infection control and offloading, patients received a saline-moistened gauze dressing (control group) for wound care.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
After conventional therapy consisting of debridement, infection control and offloading, patients received the piscean collagen dressing (the study group) for wound care.
Intervention Type
Device
Intervention Name(s)
Piscean collagen dressing
Other Intervention Name(s)
Dressing
Intervention Description
Piscean collagen dressing
Intervention Type
Device
Intervention Name(s)
Saline infused dressing
Intervention Description
Saline infused dressing
Primary Outcome Measure Information:
Title
Change in DFU size
Description
change in DFU size using the manual planimetric method
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complete wound healing
Description
Complete wound healing using three-dimensional wound measurement software
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Khan, MD
Organizational Affiliation
Punjab Care hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zainab Khan
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data can be provided upon reasonable request
Learn more about this trial
Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients
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