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

NCT03934281 | Completed

• 1 other identifier: CHMS17001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Diabete Mellitus; Amputation; Amputation Wound; Toe (Toes); Wound

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months after amputation

Secondary Outcomes (6)

• Epidermization rate at 12 months

  12 months after amputation

• pain during dressing change: verbal scale of pain

  inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization

• average length of wound cicatrization

  from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months

• the satisfaction of professionals for the use of honey dressing

  12 months after amputation or at study completion, whichever came first

• Epidermization rate at 1 month

  1 month after amputation

Study Arms (2)

HAS dressing

ACTIVE COMPARATOR

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) .

Device: HAS recommendation dressing

Honey dressing

EXPERIMENTAL

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).

Device: Honey dressing Melectis G

Interventions

Honey dressing Melectis G DEVICE

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.

Honey dressing

HAS recommendation dressing DEVICE

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.

HAS dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients
• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Hélène Blaise

Chambéry, 73011, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 1, 2019
• Study Start: June 27, 2018
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)