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Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient (MELIDIAB)

Primary Purpose

Diabete Mellitus, Amputation, Amputation Wound

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Honey dressing Melectis G
HAS recommendation dressing
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabete Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • Diabetic patients
  • Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated
  • Written informed consent.

Exclusion Criteria:

  • Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide.
  • Insipid Diabètes
  • patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy)
  • transmetatarsal amputation
  • Patient with sutured wound
  • Patient already included in the study, for a previous amputation for wich the wound has not healed.
  • Failure to comply with protocol requirements
  • Person protect by article L1121-5 to L1121-8 of the French Health Public.
  • Patient include in an other clinical study

Sites / Locations

  • Hélène Blaise

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HAS dressing

Honey dressing

Arm Description

Patients included in the "HAS dressing" arm will receive the best available dressing according to the HAS recommendations. HAS is the french National Authority for Health (HAS) .

the honey used in this study is the Melectis G dressing. This is a combination of thyme honey (99.8%) and hyaluronic acid (0.2%). The patient will benefit from the honey dressing until complete healing and/or until the end of the study (maximum 12 months).

Outcomes

Primary Outcome Measures

Epidermization rate at 6 months.
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume six months after (M6), on the volume of the wound in mm3 at J0. (TM6 = (VD0 - VM6) /VD0)

Secondary Outcome Measures

Epidermization rate at 12 months
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 12 months after (M12), on the volume of the wound in mm3 at J0. (T = (VD0 - VM12) /VD0)
pain during dressing change: verbal scale of pain
verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4.
average length of wound cicatrization
The average length of wound healing in case of complete healing before the end of the study.
the satisfaction of professionals for the use of honey dressing
the level of satisfaction of all professionals involved in the rehabilitation of the honey dressing, will be evaluated with a Likert scale.The Likert scale, which falls under our definition of a survey scale, is a 5 point scale that ranges from one extreme attitude to another, like "extremely likely" to "not at all likely." They include a moderate or neutral midpoint.
Epidermization rate at 1 month
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 1 month after (M1), on the volume of the wound in mm3 at J0. (T = (VD0 - VM1) /VD0)
Epidermization rate at 2 months
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 2 months after (M2), on the volume of the wound in mm3 at J0. (T = (VD0 - VM2) /VD0)

Full Information

First Posted
April 4, 2019
Last Updated
June 20, 2022
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT03934281
Brief Title
Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient
Acronym
MELIDIAB
Official Title
Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey. Honey is effective in the management of many infected or uninfected post-surgical wounds. This study focuses on post surgical wounds after toe amputation in diabetic patients. The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Mellitus, Amputation, Amputation Wound, Toe (Toes); Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAS dressing
Arm Type
Active Comparator
Arm Description
Patients included in the "HAS dressing" arm will receive the best available dressing according to the HAS recommendations. HAS is the french National Authority for Health (HAS) .
Arm Title
Honey dressing
Arm Type
Experimental
Arm Description
the honey used in this study is the Melectis G dressing. This is a combination of thyme honey (99.8%) and hyaluronic acid (0.2%). The patient will benefit from the honey dressing until complete healing and/or until the end of the study (maximum 12 months).
Intervention Type
Device
Intervention Name(s)
Honey dressing Melectis G
Intervention Description
The protocol includes rinsing the wound with the saline, gently drying the edge of the wound, applying a thin Mélectis®G film to the entire wound surface and covering with a secondary dressing. Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended.
Intervention Type
Device
Intervention Name(s)
HAS recommendation dressing
Intervention Description
Patients included in the standard arm will receive the best available dressing according to the HAS recommendations. Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended.
Primary Outcome Measure Information:
Title
Epidermization rate at 6 months.
Description
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume six months after (M6), on the volume of the wound in mm3 at J0. (TM6 = (VD0 - VM6) /VD0)
Time Frame
6 months after amputation
Secondary Outcome Measure Information:
Title
Epidermization rate at 12 months
Description
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 12 months after (M12), on the volume of the wound in mm3 at J0. (T = (VD0 - VM12) /VD0)
Time Frame
12 months after amputation
Title
pain during dressing change: verbal scale of pain
Description
verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4.
Time Frame
inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization
Title
average length of wound cicatrization
Description
The average length of wound healing in case of complete healing before the end of the study.
Time Frame
from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months
Title
the satisfaction of professionals for the use of honey dressing
Description
the level of satisfaction of all professionals involved in the rehabilitation of the honey dressing, will be evaluated with a Likert scale.The Likert scale, which falls under our definition of a survey scale, is a 5 point scale that ranges from one extreme attitude to another, like "extremely likely" to "not at all likely." They include a moderate or neutral midpoint.
Time Frame
12 months after amputation or at study completion, whichever came first
Title
Epidermization rate at 1 month
Description
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 1 month after (M1), on the volume of the wound in mm3 at J0. (T = (VD0 - VM1) /VD0)
Time Frame
1 month after amputation
Title
Epidermization rate at 2 months
Description
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 2 months after (M2), on the volume of the wound in mm3 at J0. (T = (VD0 - VM2) /VD0)
Time Frame
1 month after amputation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetic patients Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated Written informed consent. Exclusion Criteria: Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide. Insipid Diabètes patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy) transmetatarsal amputation Patient with sutured wound Patient already included in the study, for a previous amputation for wich the wound has not healed. Failure to comply with protocol requirements Person protect by article L1121-5 to L1121-8 of the French Health Public. Patient include in an other clinical study
Facility Information:
Facility Name
Hélène Blaise
City
Chambéry
ZIP/Postal Code
73011
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

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