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Completed

NCT Number: NCT03934281

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

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

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Key information

Conditions

Diabete Mellitus Amputation Amputation Wound Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Toe (Toes); Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hélène Blaise

Chambéry, 73011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Acronym: MELIDIAB

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 1, 2019
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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