- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091778
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended. (CHEXU 01)
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
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Salford, United Kingdom, M68hd
- Salford Royal Hospital (NHS) Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both gender ≥18 years old.
- Subjects with type 1 or 2 diabetes mellitus.
- Texas Grade A1 or 2, C1 or 2
- Exuding diabetic foot ulcer
- Ulcer localisation; below the ankle
- Signed Informed Consent.
Exclusion Criteria:
- Known allergy/hypersensitivity to the dressing.
- HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
- Wound infection requiring systemic treatment
- Subjects who will have problems following the protocol.
- Subjects included in other ongoing clinical investigation at present or during the past 30 days.
- Toe pressure less than 70 mmHg
- Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)
- Dry wounds
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fast Gelling Dressing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Peri-wound Skin
Time Frame: 12 weeks
|
Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEXU 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcers
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CytomedixCTI Clinical Trial and Consulting ServicesTerminatedDiabetic Foot Ulcers | Wounds | Pressure Ulcers | Leg UlcersUnited States
-
Smith & Nephew, Inc.CompletedDiabetic Foot Ulcers | Venous Leg UlcersUnited States, Canada
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HealthpointCompletedDiabetic Foot Ulcers (DFU) | Venous Stasis Ulcers (VSU)United States
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Arteriocyte, Inc.TerminatedDiabetic Foot Ulcers | Pressure Ulcers | Venous UlcersUnited States
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Integra LifeSciences CorporationMayo Clinic; Temple University; Samuel Merritt University; New York College of... and other collaboratorsCompletedFoot Ulcers, DiabeticUnited States
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HealthpointCompletedDiabetic Foot Ulcers | Pressure UlcersUnited States
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Oneness Biotech Co., Ltd.Completed
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Hadassah Medical OrganizationUnknown
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Systagenix Wound ManagementUnknownDiabetic Foot UlcersItaly, United States, United Kingdom, Germany, Spain
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Southern California Institute for Research and...Heritage Medical Research InstituteUnknownDiabetic Foot UlcersUnited States
Clinical Trials on Fast gelling dressing
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Molnlycke Health Care ABCompleted
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Molnlycke Health Care ABCompletedVenous Leg UlcerGermany, France, Czechia, Denmark, Poland, Sweden
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Wageningen UniversityCompleted
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Showa Inan General HospitalCompleted
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University of DelawareUniversity of Pennsylvania; Christiana Care Health Services; Indiana UniversityCompleted
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Aurora Health CareAurora BayCare Medical Center; BayCare Health SystemCompleted
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Queen's UniversityUniversity of WaterlooCompleted
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PfizerCompletedDermatitis, AtopicUnited States