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

Not Applicable

Completed

• Conditions: Diabete Mellitus; Amputation; Amputation Wound; Toe (Toes); Wound
• Interventions: Device: HAS recommendation dressing; Device: Honey dressing Melectis G

• Registration Number: NCT03934281
• Lead Sponsor: Centre Hospitalier Metropole Savoie

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-27
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAS dressing	HAS recommendation 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) .
Honey dressing	Honey dressing Melectis G	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).

Primary Outcome Measures

Name	Time	Method
Epidermization rate at 6 months.	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

Name	Time	Method
Epidermization rate at 12 months	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)
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	verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4.
average length of wound cicatrization	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.
the satisfaction of professionals for the use of honey dressing	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.
Epidermization rate at 1 month	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)
Epidermization rate at 2 months	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)

Trial Locations

Locations (1)

Hélène Blaise; 🇫🇷 Chambéry, France