Diabetic Foot UlcerHERMESNCT04831606
Blue Light Photobiomodulation Therapy on Neuroischemic Patients
A study testing debridement, Offloading and Advanced dressing in people with Diabetic Foot Ulcer, run by Emoled at 1 site in Italy.
Trial summary
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- debridement, Offloading and Advanced dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2021to 1 Jul 2024
- 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
- Patients suffering from neuro-ischemic diabetic foot ulcer grade IC or IIC according to the University of Texas Wound Classification; If the patient has two or more lesions, which may fall within the inclusion criteria, the most serious lesion (index lesion) will be selected and followed for the entire duration of the study.
- Patients who, following hospital discharge or after the first outpatient assessments, are followed by Home Care and are always monitored at the same referral center;
- Patients with type I or II diabetes, with blood glucose ≤ 10%;
- Patients willing to constantly wear the offload braces prescribed by the reference center;
- Patients with ulcer localized on the finger, lateral, plantar, or dorsal part of the foot with an extension greater than 1 sqcm;
- Patients with confirmed neuropathy with Monofilament (Semmes-Weinstein 5.07 / 10g);
Show all 9Show fewer
- Patients with ABPI between 0.7 - 0.9, ankle PA> 70mmHg, TcPO2 between 36 - 50 mmHg;
- Patients with lesions lasting between 1 and 24 months;
- Patients who understand the purpose of the Clinical Study and provide their informed consent in writing.
Who cannot join
- Patients who have participated in a clinical study with a drug or medical device for less than a month;
- Patients who are unable to understand the aims and objectives of the study;
- Patients who are bedridden or unable to walk or Patients with neoplasms;
- Patients with pressure ulcers;
- Patients who have infectious signs according to IDSA criteria;
- Patients who underwent revascularization in the previous two months;
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- Patients who have presented an acute ischemic event within the previous 3 months;
- Patients with heel injuries;
- Patients with nephropathy undergoing dialysis;
- Patients with osteomyelitis;
- Patients with Charcot's neuro-arthropathy:
- Patient on high dose corticosteroid therapy (≥ 40 mg/day);
- Patients with a history of self-harm who can voluntarily alter the course of healing;
- Patients with psychiatric disorders;
- Women who are pregnant or breastfeeding;
- Patients with pathologies or under treatment with drugs that induce photosensitization of the skin;
- Patients with a life expectancy of less than one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Prospective Randomized Controlled Study on the Efficacy of Blue Light in the Therapy of Neuro-ischemic Foot Lesions in Patients With Type I or II Diabetes in a Combined Hospital /Territory Treatment Regimen.
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients.
The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.
Read the detailed description
This study will be conducted according to the standards of Good Clinical Practice and in compliance with the principles set out in the Declaration of Helsinki, with the UNI_ISO_14155_2011 standard, and with all relevant local laws and regulations applicable to clinical trials that use patients as the research object. This clinical investigation in the various centers involved cannot begin before having received the favorable written approval of the Ethics Committee of the coordinating center and the respective Ethics Committees. The medical assistance provided to the subject is the responsibility of adequately qualified doctors, as all the centers involved in this study are centers specialized in the treatment of the pathology object of the clinical trial (Diabetology units or Diabetic Foot clinics).
During this trial, the patients' right to physical and mental integrity, the right to privacy, and the protection of data concerning them will be respected following Directive 95/46/EC.
This clinical investigation has been designed in such a way as to cause as little pain, discomfort, fear, and other foreseeable risks for the subject as possible and the degree of discomfort related to the trial itself or the treatment with the medical device in question is almost nil, considered the clinical evaluation report of the device and the safety data obtained from post-marketing surveillance.
The degree of discomfort/pain of the enrolled patients is however subject to continuous verification during the clinical trial, through a special questionnaire on the detection of discomfort connected to participation in the study in question. The risk/benefit ratio will be constantly checked throughout the trial, taking into account any adverse events / device-related accidents or non-serious side effects reported by the main investigators, and the preliminary assessment of the benefits found on patients who have completed the study process.
The principal investigator of each center is responsible for adequate conduct of the study of his own center and the coordination of the personnel involved. Must be responsible for all medical decisions relating to the study and ensure that adequate medical assistance is provided to the subject in case of adverse events. The investigator should conduct the study following the protocol agreed with the sponsor and the authorities.
To verify that the rights, safety, and well-being of enrolled patients are protected, that the data communicated are reliable and solid, and that the clinical investigation is conducted in compliance with the prescriptions of current legislation, the sponsor guarantees adequate monitoring of the conduct of this clinical investigation. The monitoring of the clinical investigation is entrusted to the sponsor's staff adequately trained. To ensure compliance with ICH/GCP guidelines and current legislation, such personnel will be responsible for ensuring that the Study is conducted in full compliance with the Standard Operating Procedures, the Protocol, and other written instructions.
The main responsibilities of the personnel carrying out the monitoring are to ensure adherence to the Protocol, to ensure that data is recorded and reported accurately and completely, and to verify that informed consent has been obtained and recorded for all subjects before they participate in the study. Researchers will be contacted at regular intervals throughout the study period. To check and verify the various documents (Data Collection Cards or CRFs and other relevant documents containing the original data) relating to the Study to verify compliance with the Protocol and to ensure the completeness, consistency, and accuracy of the recorded data.
Monitoring staff will conduct a center opening visit (SIV), a minimum of three visits during the study (MOV) to be scheduled approximately one after 1 or 2 months after SIV based on the number of patients enrolled, one at two-thirds of the enrollment and another after the observations on the last patient. Finally, once all the open issues have been resolved (open queries, clarifications, etc.), we will proceed with the center closing visit (COV). Should additional monitoring visits be necessary, the staff will schedule them with the principal investigator.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- debridement, Offloading, Advanced dressing, Blue Light Photobiomodulation
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridementProcedure or surgery
Cleaning of the wound area
OffloadingDevice
Offloading performed with a standard brace to the calf (Optima Diab, from Molliter).
Advanced dressingDevice
Protect the wound with Advanced dressing
Blue Light PhotobiomodulationDevice
2 minutes irradiation of blue light performed with EmoLED device
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Patients will receive a biweekly standard treatment at home according to the International Working Group on Diabetic Foot consisting of: Debridement of the lesion, unloading with a brace up to the calf, non-removable (except for contraindications), dressing of the wound with advanced dressings in use at the specialized center and in the home care network. Receives: Procedure: debridement; Device: Offloading; Device: Advanced dressing |
| EmoLED Arm | Experimental | Patients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication. Receives: Procedure: debridement; Device: Offloading; Device: Advanced dressing; Device: Blue Light Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healed lesions on the total lesions treated for each arm
Percentage of lesions showing a lasting and complete re-epithelialization in each group after twenty-four weeks.
Healing must be confirmed by the Principal Investigator or his staff during an outpatient visit at the reference center participating in the study
Measured: 24 weeks (20 weeks treatment plus 4 weeks post treatment observation)
Secondary outcomes (1)
Healing time
Number of days needed to reach a lasting and complete re-epithelialization within the observation period
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start31 Jul 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Why it stopped: very low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- Model description
- A double-blind pilot trial on outpatients affected by diabetic foot ulcers, followed in an integrated way by both a specialized center and the home nursing network, for a period of 24 weeks. The specialist center will characterize the patient, set the therapy, and evaluate them monthly, the nursing service will treat them at home biweekly. The physician in charge of the monthly evaluation is unaware of the patient's arm. During therapy, the patient will wear blinding glasses, the control arm will simulate the use of the device switching it on without aiming it at the wound. After a two-week pre-enrollment period to evaluate the wound progression applying only the standard care (if the wound reduces 50% or more, the patient will be excluded), the patient will be randomized into one of the study arms: the control arm will continue with the standard treatment, while the EmoLED Arm will receive EmoLED's therapy in addition to the standard treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emoled
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ospedale San Donato, University of Pisa
- Responsible party
- Sponsor
- Investigators
- Alberto Piaggesi, Doctor, Study chair, Pisa University HospitalAlessia Scatena, Doctor, Principal investigator, San Donato Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831606
- Sponsor's protocol ID
- EmoLED_DF_001
- Acronym
- HERMES
- Status last verified
- Oct 2024
- First submitted
- 2 Apr 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenhalgh DG. Management of Burns. N Engl J Med. 2019 Jun 13;380(24):2349-2359. doi: 10.1056/NEJMra1807442. No abstract available.
PubMed 31189038Mast BA, Schultz GS. Interactions of cytokines, growth factors, and proteases in acute and chronic wounds. Wound Repair Regen. 1996 Oct;4(4):411-20. doi: 10.1046/j.1524-475X.1996.40404.x.
PubMed 17309691
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Randomized Controlled Study on the Efficacy of Blue Light in the Therapy of Neuro-ischemic Foot Lesions in Patients With Type I or II Diabetes in a Combined Hospital /Territory Treatment Regimen.
- ClinicalTrials.gov ID
- NCT04831606
- Acronym / sponsor ID
- HERMES / EmoLED_DF_001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very low enrollment rate
- Enrolment
- 21 participants (actual)
- Lead sponsor
- EmoledIndustry (pharma, biotech, devices)
- Collaborators
- Ospedale San Donato, University of Pisa
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Apr 2021 (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.
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients.
The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.
Detailed description
This study will be conducted according to the standards of Good Clinical Practice and in compliance with the principles set out in the Declaration of Helsinki, with the UNI_ISO_14155_2011 standard, and with all relevant local laws and regulations applicable to clinical trials that use patients as the research object. This clinical investigation in the various centers involved cannot begin before having received the favorable written approval of the Ethics Committee of the coordinating center and the respective Ethics Committees. The medical assistance provided to the subject is the responsibility of adequately qualified doctors, as all the centers involved in this study are centers specialized in the treatment of the pathology object of the clinical trial (Diabetology units or Diabetic Foot clinics).
During this trial, the patients' right to physical and mental integrity, the right to privacy, and the protection of data concerning them will be respected following Directive 95/46/EC.
This clinical investigation has been designed in such a way as to cause as little pain, discomfort, fear, and other foreseeable risks for the subject as possible and the degree of discomfort related to the trial itself or the treatment with the medical device in question is almost nil, considered the clinical evaluation report of the device and the safety data obtained from post-marketing surveillance.
The degree of discomfort/pain of the enrolled patients is however subject to continuous verification during the clinical trial, through a special questionnaire on the detection of discomfort connected to participation in the study in question. The risk/benefit ratio will be constantly checked throughout the trial, taking into account any adverse events / device-related accidents or non-serious side effects reported by the main investigators, and the preliminary assessment of the benefits found on patients who have completed the study process.
The principal investigator of each center is responsible for adequate conduct of the study of his own center and the coordination of the personnel involved. Must be responsible for all medical decisions relating to the study and ensure that adequate medical assistance is provided to the subject in case of adverse events. The investigator should conduct the study following the protocol agreed with the sponsor and the authorities.
To verify that the rights, safety, and well-being of enrolled patients are protected, that the data communicated are reliable and solid, and that the clinical investigation is conducted in compliance with the prescriptions of current legislation, the sponsor guarantees adequate monitoring of the conduct of this clinical investigation. The monitoring of the clinical investigation is entrusted to the sponsor's staff adequately trained. To ensure compliance with ICH/GCP guidelines and current legislation, such personnel will be responsible for ensuring that the Study is conducted in full compliance with the Standard Operating Procedures, the Protocol, and other written instructions.
The main responsibilities of the personnel carrying out the monitoring are to ensure adherence to the Protocol, to ensure that data is recorded and reported accurately and completely, and to verify that informed consent has been obtained and recorded for all subjects before they participate in the study. Researchers will be contacted at regular intervals throughout the study period. To check and verify the various documents (Data Collection Cards or CRFs and other relevant documents containing the original data) relating to the Study to verify compliance with the Protocol and to ensure the completeness, consistency, and accuracy of the recorded data.
Monitoring staff will conduct a center opening visit (SIV), a minimum of three visits during the study (MOV) to be scheduled approximately one after 1 or 2 months after SIV based on the number of patients enrolled, one at two-thirds of the enrollment and another after the observations on the last patient. Finally, once all the open issues have been resolved (open queries, clarifications, etc.), we will proceed with the center closing visit (COV). Should additional monitoring visits be necessary, the staff will schedule them with the principal investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind pilot trial on outpatients affected by diabetic foot ulcers, followed in an integrated way by both a specialized center and the home nursing network, for a period of 24 weeks. The specialist center will characterize the patient, set the therapy, and evaluate them monthly, the nursing service will treat them at home biweekly. The physician in charge of the monthly evaluation is unaware of the patient's arm. During therapy, the patient will wear blinding glasses, the control arm will simulate the use of the device switching it on without aiming it at the wound. After a two-week pre-enrollment period to evaluate the wound progression applying only the standard care (if the wound reduces 50% or more, the patient will be excluded), the patient will be randomized into one of the study arms: the control arm will continue with the standard treatment, while the EmoLED Arm will receive EmoLED's therapy in addition to the standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: debridement, Device: Offloading, Device: Advanced dressingPatients will receive a biweekly standard treatment at home according to the International Working Group on Diabetic Foot consisting of: Debridement of the lesion, unloading with a brace up to the calf, non-removable (except for contraindications), dressing of the wound with advanced dressings in use at the specialized center and in the home care network. |
| EmoLED Arm | Experimental | Procedure: debridement, Device: Offloading, Device: Advanced dressing, Device: Blue Light PhotobiomodulationPatients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients suffering from neuro-ischemic diabetic foot ulcer grade IC or IIC according to the University of Texas Wound Classification; If the patient has two or more lesions, which may fall within the inclusion criteria, the most serious lesion (index lesion) will be selected and followed for the entire duration of the study.
- Patients who, following hospital discharge or after the first outpatient assessments, are followed by Home Care and are always monitored at the same referral center;
- Patients with type I or II diabetes, with blood glucose ≤ 10%;
- Patients willing to constantly wear the offload braces prescribed by the reference center;
- Patients with ulcer localized on the finger, lateral, plantar, or dorsal part of the foot with an extension greater than 1 sqcm;
Key exclusion criteria (17 listed)
- Patients who have participated in a clinical study with a drug or medical device for less than a month;
- Patients who are unable to understand the aims and objectives of the study;
- Patients who are bedridden or unable to walk or Patients with neoplasms;
- Patients with pressure ulcers;
- Patients who have infectious signs according to IDSA criteria;
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 |
|---|---|---|
| debridementCleaning of the wound area | Procedure or surgery | Control Arm, EmoLED Arm |
| OffloadingOffloading performed with a standard brace to the calf (Optima Diab, from Molliter). | Device | Control Arm, EmoLED Arm |
| Advanced dressingProtect the wound with Advanced dressing | Device | Control Arm, EmoLED Arm |
| Blue Light Photobiomodulation2 minutes irradiation of blue light performed with EmoLED device | Device | EmoLED Arm |
Primary outcome
Percentage of healed lesions on the total lesions treated for each arm
Time frame: 24 weeks (20 weeks treatment plus 4 weeks post treatment observation)
Percentage of lesions showing a lasting and complete re-epithelialization in each group after twenty-four weeks. Healing must be confirmed by the Principal Investigator or his staff during an outpatient visit at the reference center participating in the study
1 secondary outcome
Healing time
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: very low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 31189038Greenhalgh DG. Management of Burns. N Engl J Med. 2019 Jun 13;380(24):2349-2359. doi: 10.1056/NEJMra1807442. No abstract available.
- Background: PubMed 17309691Mast BA, Schultz GS. Interactions of cytokines, growth factors, and proteases in acute and chronic wounds. Wound Repair Regen. 1996 Oct;4(4):411-20. doi: 10.1046/j.1524-475X.1996.40404.x.
- Individual participant dataSharing planned: No
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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.
Alberto Piaggesi, Doctor study chair
Pisa University Hospital
Alessia Scatena, Doctor principal investigator
San Donato Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debridement, Offloading and Advanced dressing in people with Diabetic Foot Ulcer, run by Emoled at 1 site in Italy.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Nov 2024. 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 Italy. 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 was stopped early (reason given: very low enrollment rate). Results are not available in the source record.
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?
Percentage of healed lesions on the total lesions treated for each arm (time frame: 24 weeks (20 weeks treatment plus 4 weeks post treatment observation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831606, which also lists 2 linked publications.
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 27 Nov 2024.