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 Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fast Gelling Dressing

Group Type EXPERIMENTAL

Fast gelling dressing

Intervention Type DEVICE

Interventions

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Fast gelling dressing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No