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)

Centre Hospitalier Metropole Savoie

Status: Completed

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

Treatments: Device: Honey dressing Melectis G; Device: HAS recommendation dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03934281

CHMS17001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

HAS dressing

Active Comparator group

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) .

Treatment:

Device: HAS recommendation dressing

Honey dressing

Experimental group

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).

Treatment:

Device: Honey dressing Melectis G