Pressure UlcerNCT03220451
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
A study testing Adhesive elastic taping in people with Pressure Ulcer and Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Spinal Cord Injuries
- What is being tested?
- Adhesive elastic taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2017to 20 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury of any aetiology (traumatic and non-traumatic) and any neurological level, both complete and incomplete, occurred at least 3 months before;
- Pressure ulcer occurred at least 1 month before;
- Pressure ulcer staged III or IV, according to the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification;
- Pressure ulcer located in sacral or heel region;
- Pressure ulcer with cleansed bottom;
- Stable clinical conditions;
- Cognitive integrity and full collaboration of the subject.
Who cannot join
- Ulcerative skin lesion not due to pressure;
- Pressure ulcer with frank signs of infection or suggestive of underlying osteomyelitis;
- Eczema and/or irritated and/or psoriatic skin around the pressure ulcer;
- Ongoing deep venous thrombosis;
- Known allergy to elastic adhesive tape;
- Ongoing neoplasia;
Show all 14Show fewer
- Uncompensated diabetes with signs of peripheral vasculopathy;
- Evidence of peripheral polyneuropathy;
- Circulatory problems (e.g. severe lower limb artery disease);
- Significant respiratory problems (e.g. with ongoing assisted ventilation);
- Ongoing sepsis;
- Ongoing severe clinical instability;
- Ongoing oral anticoagulant therapy;
- Ongoing pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Use of Adhesive Elastic Taping as "add-on" Treatment for the Therapy of Medium/Severe Grade Pressure Ulcers in Spinal Cord Injured Patients
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. Pressure sores are one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Read more
Further treatments have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing their effectiveness and safety and they are often not decisive, especially for severe and recalcitrant ulcers.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
The Montecatone Rehabilitation Institute, that hosts the largest Spinal Unit in Italy, pays great attention to the prevention and treatment of PUs in both acute and chronic patients. The rationale for the taping positioning around PUs investigated in this study is to improve lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas of onset of pressure sores. The total shortage in the literature and in user manuals of taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled pilot study with the primary aim of verifying the safety of a taping treatment for medium/severe grade PUs, "add-on" to the usual care. The choice of the ulcer sites selected (sacral and heel) has been affected by the feasibility of tape positioning.
Read the detailed description
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. More than one-third of individuals hospitalized in Spinal Units for rehabilitative treatments following a SCI develop PUs during acute hospitalization and it was also estimated that up to 85% of SCI persons develop at least one PU in the course of their lives. Pressure sores are therefore one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Traditional treatment of PUs consists in the use of advanced dressings that may vary depending on the degree of staging of the lesion, its extent and the presence of clinical signs of necrosis and/or deep soft tissue infection. In addition to dressings, treatment cycles with intermittent negative pressure therapy can be indicated and the surgical approach (toilets + plastic reconstruction) could be reserved to chronic lesions with no response to traditional dressings or in the case of underlying osteomyelitis.
Alternative treatments (e.g. electrotherapy, pulsed electromagnetic fields, ultraviolet light, infrared radiation, laser therapy, ultrasound, shock waves) have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing the effectiveness and safety of such techniques that are often not decisive for healing, especially for severe and recalcitrant lesions.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" or "neuro taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
The Montecatone Rehabilitation Institute hosts the largest Spinal Unit in Italy as for number of beds and patients admitted. In addition to the intensive rehabilitation of SCI patients, great attention is paid to the prevention and treatment of PUs in both acute and chronic patients, involving physicians, physiotherapists and nurses. Some Physical Therapists of the Hospital are trained and experienced in the use of adhesive elastic bandage for various neuromuscular applications and a physiotherapy/nursing team has conceived, under medical supervision, the taping protocol for the PUs therapy proposed in this study. The rationale for such a taping positioning around PUs is to improve lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas of onset of pressure sores. Therefore, it is considered that, thanks to the normalization of blood and lymphatic flow, the proposed protocol may have a facilitating action to heal such lesions, especially if they are severe and recalcitrant to normal therapies.
The total shortage in the literature and in user manuals of taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled pilot study with the primary aim of verifying the safety of a taping treatment for medium/severe grade PUs, "add-on" to the usual care. The choice of the ulcer sites selected (sacral and heel) has been affected by the feasibility of tape positioning.
- Conditions
- Pressure Ulcer, Spinal Cord Injuries
- Being tested
- Adhesive elastic taping
- Keywords
- pressure ulcer, pressure sore, decubitus ulcer, spinal cord injury, adhesive elastic bandage, taping, kinesio taping, neuro taping
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive elastic tapingProcedure or surgery
Adhesive elastic taping placed around a pressure ulcer, according to a planned placement technique
| Study group | Role | What they receive |
|---|---|---|
| Adhesive elastic taping | Experimental | After a 4-week observation of the pressure ulcer under investigation, adhesive elastic tape is applied around it for a 4-week period (the tape is changed twice a week), according to a planned application protocol. The ulcer is then observed for a subsequent follow-up period of 4 weeks. Receives: Procedure: Adhesive elastic taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of possible adverse events due to the taping treatment
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
Measured: Every day, during the 4-week tape application period
Onset of possible adverse events due to the adhesive elastic taping treatment
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
Measured: Every day, during the 4-week follow-up after the tape application period
Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment
Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment
Measured: Every day (during the 4-week tape application period)
Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment
Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment
Measured: Every day (during the 4-week follow-up after the tape application period)
Secondary outcomes (16)
Evolution of the characteristics of the pressure ulcer under investigation
Pressure ulcer assessment with Bates-Jensen Wound Assessment Tool (BWAT), once a week
Measured: Baseline (initial visit); once a week during the whole study period (12 weeks)
Evolution of the characteristics of the pressure ulcer under investigation
Photographic shot of the pressure ulcer
Measured: Baseline (initial visit); week 4; week 8; week 12
Patient's weight
Patient's weight, in kilograms (kg)
Measured: Baseline (initial visit)
Patient's height
Patient's height, in meters (m)
Measured: Baseline (initial visit)
Patient's Body Mass Index (BMI)
Patient's BMI assessment (as one of the nutritional status indicators): Patient's weight and Patient's height are combined as kg/m^2
Measured: Baseline (initial visit)
Change in patient's blood hemoglobin
Dosage of blood hemoglobin (as one of the nutritional status indicators): grams per deciliter
Measured: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood number of lymphocytes:
Dosage of blood number of lymphocytes (as one of the nutritional status indicators): billions per liter
Measured: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood albumin
Dosage of blood albumin (as one of the nutritional status indicators): grams per deciliter
Measured: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood prealbumin
Dosage of blood prealbumin (as one of the nutritional status indicators): milligrams per deciliter
Measured: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood total proteins
Dosage of blood total proteins (as one of the nutritional status indicators): grams per deciliter
Measured: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood transferrin
Dosage of blood total transferrin (as one of the nutritional status indicators): milligrams per deciliter
Measured: Baseline (initial visit); week 4; week 8; week 12
Onset of patient's pain
Pain assessment with Numeric Rating Scale (NRS), twice a day (morning and evening) during the whole study period (12 weeks)
Measured: Baseline (initial visit); twice a day, during the whole study period (12 weeks)
Site of patient's pain (if any)
Description of the site of possibly observed pain, twice a day (morning and evening) during the whole study period (12 weeks)
Measured: Baseline (initial visit); twice a day, during the whole study period (12 weeks)
Change of patient's spasticity
Spasticity assessment with the Modified Ashworth Scale (MAS)
Measured: Baseline (initial visit); week 2; week 4; week 6; week 8; week 10; week 12
Tape employed for taping treatment
Quantification of total tape employed for the taping application treatment for each pressure ulcer (in meters)
Measured: End of tape application period (week 8)
Time-operator employed for taping treatment
Quantification of total time-operator employed for the taping application treatment for each pressure ulcer (in minutes)
Measured: End of tape application period (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start25 Sep 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Capirossi, MD Spinal U, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220451
- Sponsor's protocol ID
- CE-17083
- Status last verified
- Jan 2021
- First submitted
- 11 Jul 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Use of Adhesive Elastic Taping as "add-on" Treatment for the Therapy of Medium/Severe Grade Pressure Ulcers in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT03220451
- Acronym / sponsor ID
- CE-17083
- Conditions
- Pressure Ulcer, Spinal Cord Injuries
- Keywords
- pressure ulcer, pressure sore, decubitus ulcer, spinal cord injury, adhesive elastic bandage, taping, kinesio taping, neuro taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Jul 2017 (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.
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. Pressure sores are one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Further treatments have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing their effectiveness and safety and they are often not decisive, especially for severe and recalcitrant ulcers.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
The Montecatone Rehabilitation Institute, that hosts the largest Spinal Unit in Italy, pays great attention to the prevention and treatment of PUs in both acute and chronic patients. The rationale for the taping positioning around PUs investigated in this study is to improve lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas of onset of pressure sores. The total shortage in the literature and in user manuals of taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled pilot study with the primary aim of verifying the safety of a taping treatment for medium/severe grade PUs, "add-on" to the usual care. The choice of the ulcer sites selected (sacral and heel) has been affected by the feasibility of tape positioning.
Detailed description
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. More than one-third of individuals hospitalized in Spinal Units for rehabilitative treatments following a SCI develop PUs during acute hospitalization and it was also estimated that up to 85% of SCI persons develop at least one PU in the course of their lives. Pressure sores are therefore one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Traditional treatment of PUs consists in the use of advanced dressings that may vary depending on the degree of staging of the lesion, its extent and the presence of clinical signs of necrosis and/or deep soft tissue infection. In addition to dressings, treatment cycles with intermittent negative pressure therapy can be indicated and the surgical approach (toilets + plastic reconstruction) could be reserved to chronic lesions with no response to traditional dressings or in the case of underlying osteomyelitis.
Alternative treatments (e.g. electrotherapy, pulsed electromagnetic fields, ultraviolet light, infrared radiation, laser therapy, ultrasound, shock waves) have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing the effectiveness and safety of such techniques that are often not decisive for healing, especially for severe and recalcitrant lesions.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" or "neuro taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
The Montecatone Rehabilitation Institute hosts the largest Spinal Unit in Italy as for number of beds and patients admitted. In addition to the intensive rehabilitation of SCI patients, great attention is paid to the prevention and treatment of PUs in both acute and chronic patients, involving physicians, physiotherapists and nurses. Some Physical Therapists of the Hospital are trained and experienced in the use of adhesive elastic bandage for various neuromuscular applications and a physiotherapy/nursing team has conceived, under medical supervision, the taping protocol for the PUs therapy proposed in this study. The rationale for such a taping positioning around PUs is to improve lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas of onset of pressure sores. Therefore, it is considered that, thanks to the normalization of blood and lymphatic flow, the proposed protocol may have a facilitating action to heal such lesions, especially if they are severe and recalcitrant to normal therapies.
The total shortage in the literature and in user manuals of taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled pilot study with the primary aim of verifying the safety of a taping treatment for medium/severe grade PUs, "add-on" to the usual care. The choice of the ulcer sites selected (sacral and heel) has been affected by the feasibility of tape positioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adhesive elastic taping | Experimental | Procedure: Adhesive elastic tapingAfter a 4-week observation of the pressure ulcer under investigation, adhesive elastic tape is applied around it for a 4-week period (the tape is changed twice a week), according to a planned application protocol. The ulcer is then observed for a subsequent follow-up period of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord injury of any aetiology (traumatic and non-traumatic) and any neurological level, both complete and incomplete, occurred at least 3 months before;
- Pressure ulcer occurred at least 1 month before;
- Pressure ulcer staged III or IV, according to the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification;
- Pressure ulcer located in sacral or heel region;
- Pressure ulcer with cleansed bottom;
Key exclusion criteria (14 listed)
- Ulcerative skin lesion not due to pressure;
- Pressure ulcer with frank signs of infection or suggestive of underlying osteomyelitis;
- Eczema and/or irritated and/or psoriatic skin around the pressure ulcer;
- Ongoing deep venous thrombosis;
- Known allergy to elastic adhesive tape;
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 |
|---|---|---|
| Adhesive elastic tapingAdhesive elastic taping placed around a pressure ulcer, according to a planned placement technique | Procedure or surgery | Adhesive elastic taping |
Primary outcome
Onset of possible adverse events due to the taping treatment
Time frame: Every day, during the 4-week tape application period
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
Onset of possible adverse events due to the adhesive elastic taping treatment
Time frame: Every day, during the 4-week follow-up after the tape application period
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment
Time frame: Every day (during the 4-week tape application period)
Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment
Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment
Time frame: Every day (during the 4-week follow-up after the tape application period)
Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment
16 secondary outcomes
Evolution of the characteristics of the pressure ulcer under investigation
Time frame: Baseline (initial visit); once a week during the whole study period (12 weeks)
Evolution of the characteristics of the pressure ulcer under investigation
Time frame: Baseline (initial visit); week 4; week 8; week 12
Patient's weight
Time frame: Baseline (initial visit)
Patient's height
Time frame: Baseline (initial visit)
Patient's Body Mass Index (BMI)
Time frame: Baseline (initial visit)
Change in patient's blood hemoglobin
Time frame: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood number of lymphocytes:
Time frame: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood albumin
Time frame: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood prealbumin
Time frame: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood total proteins
Time frame: Baseline (initial visit); week 4; week 8; week 12
Change in patient's blood transferrin
Time frame: Baseline (initial visit); week 4; week 8; week 12
Onset of patient's pain
Time frame: Baseline (initial visit); twice a day, during the whole study period (12 weeks)
Site of patient's pain (if any)
Time frame: Baseline (initial visit); twice a day, during the whole study period (12 weeks)
Change of patient's spasticity
Time frame: Baseline (initial visit); week 2; week 4; week 6; week 8; week 10; week 12
Tape employed for taping treatment
Time frame: End of tape application period (week 8)
Time-operator employed for taping treatment
Time frame: End of tape application period (week 8)
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 20 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Rita Capirossi, MD Spinal U principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive elastic taping in people with Pressure Ulcer and Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. 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 7 inclusion and 14 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 20 Jan 2021. 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 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?
Onset of possible adverse events due to the taping treatment (time frame: Every day, during the 4-week tape application period). The study lists 4 primary outcomes in all. 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 20 Jan 2021.