Foot UlcerNCT06065488
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
A study testing ankle kinesio tap in people with Foot Ulcer, run by MTI University at 1 site in Egypt.
Trial summary
This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma … Read more about this study
- Who is it for?
- Ages 42 to 60 years
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- ankle kinesio tap
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2023to 14 Feb 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 42 to 60 years
- All sexes
- No healthy volunteers
- Adult
- Inclusion Criteria: The subject selection will be according to the following criteria:
- Undergoing treatment for a Wagner grade II or III diabetic foot ulcer
- Age between 42 and 60 years.
- No systemic diseases such as musculoskeletal disorders, heart diseases, or neurological diseases that can hinder ability to participate in the study
- Not receiving other treatments that could affect wound healing (negative-pressure wound treatment, hyperbaric oxygen treatment, a special wound care product, special wound dressing, or growth factor.
- Not using another complementary treatment method (herbal wound care products and Participating subjects were required to be able to walk 10 m unassisted.
- Absence of protective sensation on the plantar foot as determined using a 10-gram monofilament following criteria from the International Working Group on the Diabetic Foot 2023
- All the patients have active unilateral plantar DFU at least 1cm2 (greatest length x greatest width) and not healed > 3months duration. Never received the same intervention from other researchers and health Professionals..
- Ability to walk independently for 30 steps or 10 min.
- Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- Patients with inadequate vascular circulation (ankle-brachial pressure index <0.8 or toe systolic blood pressure <40 mmHg)
- Patient with skin allergy with generalized osteoporosis, or who had fractures of any bones in the lower extremity.
- Previous ankle pathology or surgery to the lower limb within the last 12 months, current illness or infection, neurological deficits affecting the lower limb and skin conditions or edema affecting the lower limb ,Severe uncontrolled hypertension.
- Pregnant women.
- Un controlled diabetes
- Pedal amputations and arthritis.
- Ulcer developed secondary to acute trauma; ulcer developed secondary to burns.
- Foot deformities included hallux valgus, hallux rigidus, pes planus, pes cavus, low forefoot arch, and hammer toes, Skin callosities, heel fissures, a hypotrophic fat pad, and nail deformities
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma - private clinic.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Read the detailed description
Design of the study: Randomized controlled trial.
Subject's selection:
Estimated sample size is 70 subjects the actual sample size will be calculated after pilot study. They will be assigned into two equal groups:
- Group A (Ankle KT group): This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months; they will receive functional ankle taping, medical treatment, and dressing according their cases. The tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated (Andrýsková et al., 2020)
- Group B (Control group Ankle shame KT ):
This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months. Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension , they will receive medical treatment, and dressing according their cases The shame tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated. (Andrýsková et al., 2020) Patients were followed for 8 weeks or until ulcer healing, whichever came first. The protocol was designed according to the fundamental treatment principal of the expert panel to the 2022 American Diabetic Association consensus development conference on diabetic foot wound care.
- Conditions
- Foot Ulcer
- Being tested
- ankle kinesio tap
- Keywords
- plantar foot ulcers, ankle kinesiotap, wound healing, chronic wounds, diabetic patients
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle kinesio tapDevice
Kinesio Tape is popular among athletes and non-athletes for its ability to protect, support, and promote activity in overworked muscles. Few people are aware, however, that its healing benefits don't end there. Research studies show that taping ankle with Kinesio Tape actually improves ankle range of motion.
| Study group | Role | What they receive |
|---|---|---|
| 1.Group A (Ankle KT group): | Experimental | This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months; they will receive functional ankle taping, medical treatment, and dressing according their cases. The tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated (Andrýsková et al., 2020) Receives: Device: ankle kinesio tap |
| 2.Group B (Control group Ankle shame KT ): | Sham comparator | This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months. Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension , they will receive medical treatment, and dressing according their cases The shame tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated. (Andrýsková et al., 2020) Receives: Device: ankle kinesio tap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plantar peak pressures of ulcerated foot
Maximum plantar peak pressures were measured using Tekscan® pressure mat system (Boston , MA). - Patients were given time to familiarise themselves with the protocol. - Prior to testing he mat was calibrated for each individual's mass using mat-Scan® System Research software (Tekscan, Boston, MA). - Once calibration was completed Patient was asked to walk across the plantar pressure mat which placed in the center of walkway - The method has been previously validated and involves each participant taking two steps before landing on the pressure mat. - Trials were excluded and repeated if a participant appeared to target the platform and alter their gait pattern to ensure full contact with the mat - - Collecting data from mat-based Stride way System, a 150 cm long and 60 cm Wide to generate maximum Peake pressure by quantifying the pressure exerted on the force sensors\ - Direct cont
Measured: Baseline then after 8 weeks
Secondary outcomes (3)
Ankle dorsiflexion range of motion of ulcerated foot
The maximum dorsiflexion angle at the ankle joint was measured with hand - held standard goniometer in a standing position with the knee extended, with the heel in contact with the ground. Participants were asked to lean forward, directing their knees toward the wall. While the participant maintained his or her maximal dorsiflexion position, a standard goniometer was aligned with floor (stable arm) and through the shaft of the fibula (mobile arm) by visually bisecting the lateral malleolus and the fibular head. Participants were allowed three practice trials.
Measured: Baseline then after 8 weeks
Wound surface area by +Wound Desk mobile application
To start working with the application, it is required to sign in into the account. A patient's profile is completed; where it is required to indicate the location and how the trauma happened (one of several options is offered). Based on the completed profile of the dynamic monitoring process, one of standard treatment options is offered. To obtain photos, Take anew photo mode is selected in the application, which turns on the mobile application photo camera. +WD indicator should be placed next to the studied wound. The wound area is photographed, and the program recognizes +WD marker thereafter and requires a manual detection of wound borders using a thumb knob. Next, an automatic calculation of the wound surface area is performed and the result is provided
Measured: Baseline then after 8 weeks
Wound volume assessment
- Using sterilized siring and saline solution. - Filing the sterilized siring of 5 cm3 with saline solution. - Then filing the wound by the kwon volume of the saline solution - It is an easy accurate method for wound volume estimation
Measured: Baseline then after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start6 Oct 2023
- Primary completion26 Jan 2024
- Study completion14 Feb 2024
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 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
- Investigators
- El fahl, ph.d, Study chair, faculty of physical therapy .Modern university for information and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065488
- Sponsor's protocol ID
- P.T.REC/012/004688
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bus SA, van Deursen RW, Armstrong DG, Lewis JE, Caravaggi CF, Cavanagh PR; International Working Group on the Diabetic Foot. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:99-118. doi: 10.1002/dmrr.2702.
PubMed 26342178Lazzarini PA, Jarl G, Gooday C, Viswanathan V, Caravaggi CF, Armstrong DG, Bus SA. Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review. Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1(Suppl 1):e3275. doi: 10.1002/dmrr.3275.
PubMed 32176438
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06065488
- Acronym / sponsor ID
- P.T.REC/012/004688
- Conditions
- Foot Ulcer
- Keywords
- plantar foot ulcers, ankle kinesiotap, wound healing, chronic wounds, diabetic patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 4 Oct 2023 (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 study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma - private clinic.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Detailed description
Design of the study: Randomized controlled trial.
Subject's selection:
Estimated sample size is 70 subjects the actual sample size will be calculated after pilot study. They will be assigned into two equal groups:
- Group A (Ankle KT group): This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months; they will receive functional ankle taping, medical treatment, and dressing according their cases. The tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated (Andrýsková et al., 2020)
- Group B (Control group Ankle shame KT ):
This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months. Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension , they will receive medical treatment, and dressing according their cases The shame tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated. (Andrýsková et al., 2020) Patients were followed for 8 weeks or until ulcer healing, whichever came first. The protocol was designed according to the fundamental treatment principal of the expert panel to the 2022 American Diabetic Association consensus development conference on diabetic foot wound care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 1.Group A (Ankle KT group): | Experimental | Device: ankle kinesio tapThis group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months; they will receive functional ankle taping, medical treatment, and dressing according their cases. The tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated (Andrýsková et al., 2020) |
| 2.Group B (Control group Ankle shame KT ): | Sham comparator | Device: ankle kinesio tapThis group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months. Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension , they will receive medical treatment, and dressing according their cases The shame tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated. (Andrýsková et al., 2020) |
Who may qualify
- Ages
- 42 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| ankle kinesio tapKinesio Tape is popular among athletes and non-athletes for its ability to protect, support, and promote activity in overworked muscles. Few people are aware, however, that its healing benefits don't end there. Research studies show that taping ankle with Kinesio Tape actually improves ankle range of motion. | Device | 1.Group A (Ankle KT group):, 2.Group B (Control group Ankle shame KT ): |
Primary outcome
Maximum plantar peak pressures of ulcerated foot
Time frame: Baseline then after 8 weeks
Maximum plantar peak pressures were measured using Tekscan® pressure mat system (Boston , MA). - Patients were given time to familiarise themselves with the protocol. - Prior to testing he mat was calibrated for each individual's mass using mat-Scan® System Research software (Tekscan, Boston, MA). - Once calibration was completed Patient was asked to walk across the plantar pressure mat which placed in the center of walkway - The method has been previously validated and involves each participant taking two steps before landing on the pressure mat. - Trials were excluded and repeated if a participant appeared to target the platform and alter their gait pattern to ensure full contact with the mat - - Collecting data from mat-based Stride way System, a 150 cm long and 60 cm Wide to generate maximum Peake pressure by quantifying the pressure exerted on the force sensors\ - Direct cont
3 secondary outcomes
Ankle dorsiflexion range of motion of ulcerated foot
Time frame: Baseline then after 8 weeks
Wound surface area by +Wound Desk mobile application
Time frame: Baseline then after 8 weeks
Wound volume assessment
Time frame: Baseline then after 8 weeks
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 19 Sep 2024.
- Background: PubMed 26342178Bus SA, van Deursen RW, Armstrong DG, Lewis JE, Caravaggi CF, Cavanagh PR; International Working Group on the Diabetic Foot. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:99-118. doi: 10.1002/dmrr.2702.
- Background: PubMed 32176438Lazzarini PA, Jarl G, Gooday C, Viswanathan V, Caravaggi CF, Armstrong DG, Bus SA. Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review. Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1(Suppl 1):e3275. doi: 10.1002/dmrr.3275.
- Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic reviewLink provided by the sponsor.
- 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.
El fahl, ph.d study chair
faculty of physical therapy .Modern university for information and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ankle kinesio tap in people with Foot Ulcer, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Sep 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Maximum plantar peak pressures of ulcerated foot (time frame: Baseline then after 8 weeks). 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 NCT06065488, 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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.