Diabete MellitusMELIDIABNCT03934281
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
A study testing Honey dressing Melectis G and HAS recommendation dressing in people with Diabete Mellitus and Amputation, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Amputation, Amputation Wound
- What is being tested?
- Honey dressing Melectis G and HAS recommendation dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2018to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Honey dressing Melectis G, HAS recommendation dressing
- Medical subject headings
- Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey dressing Melectis GDevice
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 dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: 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). Receives: Device: Honey dressing Melectis G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months after amputation
Secondary outcomes (6)
Epidermization rate at 12 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 12 months after (M12), on the volume of the wound in mm3 at J0. (T = (VD0 - VM12) /VD0)
Measured: 12 months after amputation
pain during dressing change: verbal scale of pain
verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4.
Measured: 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
The average length of wound healing in case of complete healing before the end of the study.
Measured: 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
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.
Measured: 12 months after amputation or at study completion, whichever came first
Epidermization rate at 1 month
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)
Measured: 1 month after amputation
Epidermization rate at 2 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 2 months after (M2), on the volume of the wound in mm3 at J0. (T = (VD0 - VM2) /VD0)
Measured: 1 month after amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start27 Jun 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934281
- Sponsor's protocol ID
- CHMS17001
- Acronym
- MELIDIAB
- Status last verified
- Jun 2022
- First submitted
- 4 Apr 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03934281
- Acronym / sponsor ID
- MELIDIAB / CHMS17001
- Conditions
- Diabete Mellitus, Amputation, Amputation Wound, Toe (Toes); Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAS dressing | Active comparator | Device: HAS recommendation dressingPatients 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 | Experimental | Device: Honey dressing Melectis Gthe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey dressing Melectis GThe 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. | Device | Honey dressing |
| HAS recommendation dressingPatients 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. | Device | HAS dressing |
Primary outcome
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)
6 secondary outcomes
Epidermization rate at 12 months
Time frame: 12 months after amputation
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
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 satisfaction of professionals for the use of honey dressing
Time frame: 12 months after amputation or at study completion, whichever came first
Epidermization rate at 1 month
Time frame: 1 month after amputation
Epidermization rate at 2 months
Time frame: 1 month after amputation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Diabete Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey dressing Melectis G and HAS recommendation dressing in people with Diabete Mellitus and Amputation, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidermization rate at 6 months. (time frame: 6 months after amputation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.