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)

• ClinicalTrials.gov Identifier: NCT03934281
• Recruitment Status: Unknown
• First Posted: May 1, 2019
• Last Update Posted: January 6, 2020
• Sponsor: Centre Hospitalier Metropole Savoie
• Information provided by (Responsible Party): Centre Hospitalier Metropole Savoie

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

Condition or disease	Intervention/treatment	Phase
Diabete Mellitus; Amputation; Amputation Wound; Toe (Toes); Wound	Device: Honey dressing Melectis G; Device: HAS recommendation dressing	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 27, 2018
• Estimated Primary Completion Date: June 27, 2021
• Estimated Study Completion Date: December 27, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: HAS dressing; 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; 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.
Experimental: Honey dressing; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Epidermization rate at 6 months. [ Time Frame: 6 months after amputation ]
   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 :

1. Epidermization rate at 12 months [ Time Frame: 12 months after amputation ]
   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)
2. pain during dressing change: verbal scale of pain [ 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 ]
   verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4.
3. average length of wound cicatrization [ Time Frame: from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months ]
   The average length of wound healing in case of complete healing before the end of the study.
4. the satisfaction of professionals for the use of honey dressing [ Time Frame: 12 months after amputation or at study completion, whichever came first ]
   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.
5. Epidermization rate at 1 month [ Time Frame: 1 month after amputation ]
   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)
6. Epidermization rate at 2 months [ Time Frame: 1 month after amputation ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Hélène Blaise; 04.79.96.50.50 ext 33; Helene.Blaise@ch-metropole-savoie.fr

Contact: Damien Bertoncini; 04.79.96.50.50 ext 33; damien.bertoncini@ch-metropole-savoie.fr

Locations

France

Hélène Blaise; Recruiting

Chambéry, France, 73011

Contact: Marie-Christine CARRET 0479965999 ext 33 mariechristine.carret@ch-metropole-savoie.fr

Contact: Fabienne Prieur 0479965999 ext 33 fabienne.prieur@ch-metropole-savoie.fr

Sub-Investigator: Maurine Oreglia

Sub-Investigator: Domitile Guedel

Principal Investigator: Hélène Blaise

Sub-Investigator: Maxime Moulin

Sub-Investigator: Pauline Gélibert

Sponsors and Collaborators

Centre Hospitalier Metropole Savoie

More Information

• Responsible Party: Centre Hospitalier Metropole Savoie
• ClinicalTrials.gov Identifier: NCT03934281
• Other Study ID Numbers: CHMS17001
• First Posted: May 1, 2019
• Last Update Posted: January 6, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases