Skin TagsHUM_FIBNCT04161274
Randomized Clinical Trial on Skin Tags Approachment.
A study testing Traditional method: Electrosurgery, Traditional method: Cryotherapy and Traditional method: Silver nitrate in people with Skin Tags, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Skin tags are a benign dermal disease very frequent in the general population. Their exeresis is indicated in case of discomfort of the affected person (usually because of friction or increase in size). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Tags
- What is being tested?
- Traditional method: Electrosurgery, Traditional method: Cryotherapy and Traditional method: Silver nitrate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 1 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Injuries that, by increasing in size or by rubbing with some element of clothing, cause discomfort for the user (pain, bleeding, ...).
- Only small skin tags (≤0,5x0,5cm) will be accepted for study.
- People who voluntarily agree to enter the clinical trial and sign the Informed Consent.
Who cannot join
- Immunosuppressed patients: people with immunosuppressive treatments, long-lasting corticoids, chemotherapy or radiotherapy, biological treatments and immunosuppressive diseases such as HIV infection, hematological diseases, transplants... (these people have a compromised immune response and are more susceptible to infections and their complications.
- Patients with anticoagulant treatment: oral anticoagulants antagonists of vitamin K (AVK: acenocoumarol, warfarin) or direct oral anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban, edoxaban).
- According to location: those areas of greater risk of infection due to their location (genital areas) or those areas with aesthetic compromise.
- According to size: in order to ensure the homogeneity of the lesions, large lesions (larger than 0,5x0,5cm) will be discarded.
- Allergic to silver (according to medical history or patient reference).
- Lesions of doubtful diagnosis. Skin tag is a benign lesion but any doubt in its diagnostic classification will be an exclusion criterion in its participation. In these cases, it will be treated according to the centre usual minor surgery protocol for study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on Traditional Healing Versus Moist Healing Environment (MHE) Applied to Minor Surgery in the Exeresis of Skin Tags
Skin tags are a benign dermal disease very frequent in the general population. Their exeresis is indicated in case of discomfort of the affected person (usually because of friction or increase in size). In the minor surgery guidelines, their extraction is recommended with cryotherapy, electrocoagulation or shaving with cauterization of silver nitrate (traditional healing techniques).
This randomized clinical trial proposes its extraction with a non before referenced technique in the manuals of minor surgery and that is nowadays applied with very good outcomes in the domain of pressure ulcers, chronic wounds and, in recent years, in acute wounds; the moist healing environment. Therefore, the investigators propose the surgical exeresis of the fibroid in the most proximal part of the pendulum with the subsequent placement of a thin hydrocolloid dressing.
Read more
The objective of this trial is to compare the traditional healing with the moist healing environment in minor surgery, analyzing costs, time invested by the professional, healing time and their respective complications.
Expected results: faster healing and lower cost are expected with the new technique. By contrast, more complications are expected in the techniques of cryotherapy and silver nitrate.
Applicability / Relevance: it is a common pathology usually treated in the minor surgery office or routine visit. Therefore, it can show us which treatment leads to fewer complications for the patient and which is more cost-efficient for the health system.
Read the detailed description
Study variables:
- Sex: Dichotomous qualitative variable: woman/man. Clinical history collection.
- Age: Discrete quantitative variable in years from the date of birth included in the clinical history.
- Family history. Dichotomous qualitative variable: yes/no. According to the interview with the participant, the family history of first and second degree skin tags will be considered.
- Location of the lesion. Qualitative variable categorized in 6 items: Trunk/ armpit/ neck/ inguinal/ upper extremity/ lower extremity.
- Diabetes Dichotomous qualitative variable: yes/no. According to conditioning factors and problems in the clinical history and interview with the participant. There are studies that relate insulin resistance with the presence or not of skin tags 37, 38. To be able to study if the results obtained are independent of the variable of suffering from DM.
- Cost: Continuous quantitative variable, expressed in euros. The cost will include the performance of the technique in the first minor surgery visit, the post-surgical cures and the follow-up visits. The standardized cost of each of the interventions has been calculated according to the different techniques for approaching skin tag, from the prices published in DOGC 6326 of 1 March 2013 Resolution SLT/353/2013 of 13 February on the review of public price corresponding to the health services provided by the Institut Català de la Salut. Apart from the price for the minor surgery visit of the different approaches, the price of the follow-up visits has been calculated in case of prolonged healing time of the lesion or the appearance of complications (infection or non-viable tissue...).
- Healing time: Discrete quantitative variable expressed in days. It will be considered 'healing' when the lesion has concluded the phases of inflammation and granulation/epithelialization. It will be the moment when it does not require any cure and lacks non-viable tissue (the days in the remodeling phase in which the participant uses skin care such as moisturizing, sun protection... will not be counted). For the monitoring of this variable, in the follow-up visits, the state of scarring will be evaluated and if it is already healed, it will be asked on what day prior to the visit, the lesion did not need any special cure and lacked non-viable tissue.
- Time invested by the professional: Discrete quantitative variable expressed in minutes. The time invested in each visit will be recorded until it is healed.
- Complications:
Infection: Dichotomous qualitative variable: yes/no. Infection is considered when the wound shows inflammation signs of infection.
- Devitalized tissue: Dichotomous qualitative variable: yes/no. The appearance of slough will be observed.
- Technique: Qualitative variable categorized in 4 items:
- Dry Cure - Electrocoagulation.
- Dry Cure - Cryotherapy.
- Dry Cure - Silver Nitrate.
- Cure in a moist healing environment.
- Conditions
- Skin Tags
- Being tested
- Traditional method: Electrosurgery, Traditional method: Cryotherapy, Traditional method: Silver nitrate, Moist healing environment method
- Keywords
- minor surgery procedures, wounds and injuries, moist healing environment, fibroma, nursing, skin diseases
- Medical subject headings
- Wounds and Injuries, Fibroma, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional method: ElectrosurgeryProcedure or surgery
The patient will be prepared before this technique by removing all metal objects in his possession. The area should be disinfected with a local antiseptic, leaving the area aseptic. Afterwards, perilesional infiltrated local anaesthesia (subcutaneous or intradermal) will be applied. Once the area has been anaesthetised, excision is made with scissors cutting through the most proximal part of the skin tag pendulum and the lesion is coagulated with the handle or knife of the electrocoagulator (previously regulated with the intensity in coagulation mode). The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed.
Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight.
Traditional method: CryotherapyProcedure or surgery
The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. for a few minutes the tip of an Adson forceps will be introduced in a container with liquid nitrogen until freezing. It will then be applied to the most proximal part of the skin tag pendulum until it is observed that the frostbite has reached the base of the lesion and the surface becomes whitish, with a halo of 1-3 mm. When this happens, it will be excise above the frost part in the pendulum. After application, it is disinfected with povidone- iodine and covered with a protective dressing of sterile occlusive gauze plaster. It will then form an eschar. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight.
Traditional method: Silver nitrateProcedure or surgery
The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag cutting through the most proximal part of the skin tag pendulum, then cauterized with the tip of the silver nitrate rod, trying not to apply in the perilesional zone.
The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed.
Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or solar rays.
Moist healing environment methodProcedure or surgery
The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag by cutting through the most proximal part of the pendulum of the skin tag, later it will be disinfected with chlorhexidine and thin hydrocolloid dressing will be placed. Indications to the patient: the project participant will be told not to touch the dressing until the next control after 3 days with the research team. In case of incidents with the dressing (fall of the dressing), the patient will be given a replacement dressing for this purpose and be able to restore it immediately. It is recommended not to expose the area to the solar rays
| Study group | Role | What they receive |
|---|---|---|
| Traditional method: Electrosurgery | Active comparator | Local anaesthesia and excision with a scalpel connected to the electric current, according to the voltage. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit.
Follow-up visits every 3 days until the lesions cicatrization. Receives: Procedure: Traditional method: Electrosurgery |
| Traditional method: Cryotherapy | Active comparator | Application of liquid nitrogen to cause freezing. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit.
Follow-up visits every 3 days until the lesions cicatrization. Receives: Procedure: Traditional method: Cryotherapy |
| Traditional method: Silver nitrate | Active comparator | Excision is made with the scissors and a rod is applied containing silver nitrate with caustic power on the wound.
Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit.
Follow-up visits every 3 days until the lesions cicatrization. Receives: Procedure: Traditional method: Silver nitrate |
| Moist healing environment | Experimental | Excision is made with the scissors, afterwards pressure, clorhexidine and a hydrocolloid dressing when the skin is dry.
Photograph to the lesion before and after the intervention and in each follow-up visit.
Follow-up visits every 3 days until the lesions cicatrization. Receives: Procedure: Moist healing environment method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Discrete quantitative variable expressed in days. It will be considered 'healing' when the lesion has concluded the phases of inflammation and granulation/epithelialization. It will be the moment when it does not require any cure and lacks non-viable tissue (the days in the remodeling phase in which the participant uses skin care such as moisturizing, sun protection... will not be counted). For the monitoring of this variable, in the follow-up visits, the state of scarring will be evaluated and if it is already healed, it will be asked on what day prior to the visit, the lesion did not need any special cure and lacked non-viable tissue.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TagsStudies 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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Paloma Fürstenheim Milerud, Principal investigator, ICSGemma Amat i Camats, Principal investigator, ICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161274
- Sponsor's protocol ID
- IDIAP JordiGol
- Acronym
- HUM_FIB
- Status last verified
- Jul 2019
- First submitted
- 26 Sep 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Traditional Healing Versus Moist Healing Environment (MHE) Applied to Minor Surgery in the Exeresis of Skin Tags
- ClinicalTrials.gov ID
- NCT04161274
- Acronym / sponsor ID
- HUM_FIB / IDIAP JordiGol
- Conditions
- Skin Tags
- Keywords
- minor surgery procedures, wounds and injuries, moist healing environment, fibroma, nursing, skin diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 Nov 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.
Skin tags are a benign dermal disease very frequent in the general population. Their exeresis is indicated in case of discomfort of the affected person (usually because of friction or increase in size). In the minor surgery guidelines, their extraction is recommended with cryotherapy, electrocoagulation or shaving with cauterization of silver nitrate (traditional healing techniques).
This randomized clinical trial proposes its extraction with a non before referenced technique in the manuals of minor surgery and that is nowadays applied with very good outcomes in the domain of pressure ulcers, chronic wounds and, in recent years, in acute wounds; the moist healing environment. Therefore, the investigators propose the surgical exeresis of the fibroid in the most proximal part of the pendulum with the subsequent placement of a thin hydrocolloid dressing.
The objective of this trial is to compare the traditional healing with the moist healing environment in minor surgery, analyzing costs, time invested by the professional, healing time and their respective complications.
Expected results: faster healing and lower cost are expected with the new technique. By contrast, more complications are expected in the techniques of cryotherapy and silver nitrate.
Applicability / Relevance: it is a common pathology usually treated in the minor surgery office or routine visit. Therefore, it can show us which treatment leads to fewer complications for the patient and which is more cost-efficient for the health system.
Detailed description
Study variables:
- Sex: Dichotomous qualitative variable: woman/man. Clinical history collection.
- Age: Discrete quantitative variable in years from the date of birth included in the clinical history.
- Family history. Dichotomous qualitative variable: yes/no. According to the interview with the participant, the family history of first and second degree skin tags will be considered.
- Location of the lesion. Qualitative variable categorized in 6 items: Trunk/ armpit/ neck/ inguinal/ upper extremity/ lower extremity.
- Diabetes Dichotomous qualitative variable: yes/no. According to conditioning factors and problems in the clinical history and interview with the participant. There are studies that relate insulin resistance with the presence or not of skin tags 37, 38. To be able to study if the results obtained are independent of the variable of suffering from DM.
- Cost: Continuous quantitative variable, expressed in euros. The cost will include the performance of the technique in the first minor surgery visit, the post-surgical cures and the follow-up visits. The standardized cost of each of the interventions has been calculated according to the different techniques for approaching skin tag, from the prices published in DOGC 6326 of 1 March 2013 Resolution SLT/353/2013 of 13 February on the review of public price corresponding to the health services provided by the Institut Català de la Salut. Apart from the price for the minor surgery visit of the different approaches, the price of the follow-up visits has been calculated in case of prolonged healing time of the lesion or the appearance of complications (infection or non-viable tissue...).
- Healing time: Discrete quantitative variable expressed in days. It will be considered 'healing' when the lesion has concluded the phases of inflammation and granulation/epithelialization. It will be the moment when it does not require any cure and lacks non-viable tissue (the days in the remodeling phase in which the participant uses skin care such as moisturizing, sun protection... will not be counted). For the monitoring of this variable, in the follow-up visits, the state of scarring will be evaluated and if it is already healed, it will be asked on what day prior to the visit, the lesion did not need any special cure and lacked non-viable tissue.
- Time invested by the professional: Discrete quantitative variable expressed in minutes. The time invested in each visit will be recorded until it is healed.
- Complications:
Infection: Dichotomous qualitative variable: yes/no. Infection is considered when the wound shows inflammation signs of infection.
- Devitalized tissue: Dichotomous qualitative variable: yes/no. The appearance of slough will be observed.
- Technique: Qualitative variable categorized in 4 items:
- Dry Cure - Electrocoagulation.
- Dry Cure - Cryotherapy.
- Dry Cure - Silver Nitrate.
- Cure in a moist healing environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional method: Electrosurgery | Active comparator | Procedure: Traditional method: ElectrosurgeryLocal anaesthesia and excision with a scalpel connected to the electric current, according to the voltage. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization. |
| Traditional method: Cryotherapy | Active comparator | Procedure: Traditional method: CryotherapyApplication of liquid nitrogen to cause freezing. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization. |
| Traditional method: Silver nitrate | Active comparator | Procedure: Traditional method: Silver nitrateExcision is made with the scissors and a rod is applied containing silver nitrate with caustic power on the wound. Traditional cure with alcohol/Betadine. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization. |
| Moist healing environment | Experimental | Procedure: Moist healing environment methodExcision is made with the scissors, afterwards pressure, clorhexidine and a hydrocolloid dressing when the skin is dry. Photograph to the lesion before and after the intervention and in each follow-up visit. Follow-up visits every 3 days until the lesions cicatrization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Injuries that, by increasing in size or by rubbing with some element of clothing, cause discomfort for the user (pain, bleeding, ...).
- Only small skin tags (≤0,5x0,5cm) will be accepted for study.
- People who voluntarily agree to enter the clinical trial and sign the Informed Consent.
Key exclusion criteria (6 listed)
- Immunosuppressed patients: people with immunosuppressive treatments, long-lasting corticoids, chemotherapy or radiotherapy, biological treatments and immunosuppressive diseases such as HIV infection, hematological diseases, transplants... (these people have a compromised immune response and are more susceptible to infections and their complications.
- Patients with anticoagulant treatment: oral anticoagulants antagonists of vitamin K (AVK: acenocoumarol, warfarin) or direct oral anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban, edoxaban).
- According to location: those areas of greater risk of infection due to their location (genital areas) or those areas with aesthetic compromise.
- According to size: in order to ensure the homogeneity of the lesions, large lesions (larger than 0,5x0,5cm) will be discarded.
- Allergic to silver (according to medical history or patient reference).
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 |
|---|---|---|
| Traditional method: ElectrosurgeryThe patient will be prepared before this technique by removing all metal objects in his possession. The area should be disinfected with a local antiseptic, leaving the area aseptic. Afterwards, perilesional infiltrated local anaesthesia (subcutaneous or intradermal) will be applied. Once the area has been anaesthetised, excision is made with scissors cutting through the most proximal part of the skin tag pendulum and the lesion is coagulated with the handle or knife of the electrocoagulator (previously regulated with the intensity in coagulation mode). The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight. | Procedure or surgery | Traditional method: Electrosurgery |
| Traditional method: CryotherapyThe patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. for a few minutes the tip of an Adson forceps will be introduced in a container with liquid nitrogen until freezing. It will then be applied to the most proximal part of the skin tag pendulum until it is observed that the frostbite has reached the base of the lesion and the surface becomes whitish, with a halo of 1-3 mm. When this happens, it will be excise above the frost part in the pendulum. After application, it is disinfected with povidone- iodine and covered with a protective dressing of sterile occlusive gauze plaster. It will then form an eschar. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight. | Procedure or surgery | Traditional method: Cryotherapy |
| Traditional method: Silver nitrateThe patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag cutting through the most proximal part of the skin tag pendulum, then cauterized with the tip of the silver nitrate rod, trying not to apply in the perilesional zone. The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or solar rays. | Procedure or surgery | Traditional method: Silver nitrate |
| Moist healing environment methodThe patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag by cutting through the most proximal part of the pendulum of the skin tag, later it will be disinfected with chlorhexidine and thin hydrocolloid dressing will be placed. Indications to the patient: the project participant will be told not to touch the dressing until the next control after 3 days with the research team. In case of incidents with the dressing (fall of the dressing), the patient will be given a replacement dressing for this purpose and be able to restore it immediately. It is recommended not to expose the area to the solar rays | Procedure or surgery | Moist healing environment |
Primary outcome
Healing time
Time frame: through study completion, an average of 1 year
Discrete quantitative variable expressed in days. It will be considered 'healing' when the lesion has concluded the phases of inflammation and granulation/epithelialization. It will be the moment when it does not require any cure and lacks non-viable tissue (the days in the remodeling phase in which the participant uses skin care such as moisturizing, sun protection... will not be counted). For the monitoring of this variable, in the follow-up visits, the state of scarring will be evaluated and if it is already healed, it will be asked on what day prior to the visit, the lesion did not need any special cure and lacked non-viable tissue.
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 29 Jul 2020.
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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.
Laura Paloma Fürstenheim Milerud principal investigator
ICS
Gemma Amat i Camats principal investigator
ICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional method: Electrosurgery, Traditional method: Cryotherapy and Traditional method: Silver nitrate in people with Skin Tags, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 6 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 29 Jul 2020. 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 Spain. 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?
Healing time (time frame: through study completion, an average of 1 year). 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 29 Jul 2020.