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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)

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fast gelling dressing
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Both gender ≥18 years old.
  2. Subjects with type 1 or 2 diabetes mellitus.
  3. Texas Grade A1 or 2, C1 or 2
  4. Exuding diabetic foot ulcer
  5. Ulcer localisation; below the ankle
  6. Signed Informed Consent.

Exclusion Criteria:

  1. Known allergy/hypersensitivity to the dressing.
  2. HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
  3. Wound infection requiring systemic treatment
  4. Subjects who will have problems following the protocol.
  5. Subjects included in other ongoing clinical investigation at present or during the past 30 days.
  6. Toe pressure less than 70 mmHg
  7. Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)
  8. Dry wounds

Sites / Locations

  • Royal Infirmary of Edinburgh
  • Salford Royal Hospital (NHS) Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fast Gelling Dressing

Arm Description

Outcomes

Primary Outcome Measures

Change in 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

Secondary Outcome Measures

Full Information

First Posted
March 18, 2014
Last Updated
January 26, 2016
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02091778
Brief Title
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.
Acronym
CHEXU 01
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fast Gelling Dressing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fast gelling dressing
Primary Outcome Measure Information:
Title
Change in Peri-wound Skin
Description
Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Salford Royal Hospital (NHS) Foundation Trust
City
Salford
ZIP/Postal Code
M68hd
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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.

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