Back to resultsFunctional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Primary Purpose
Foot Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ankle kinesio tap
Sponsored by
About this trial
This is an interventional treatment trial for Foot Ulcer focused on measuring plantar foot ulcers, ankle kinesiotap, wound healing, chronic wounds, diabetic patients
Eligibility Criteria
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
Sites / Locations
- Ahmed Mohamed Ahmed AbdelhadyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1.Group A (Ankle KT group):
2.Group B (Control group Ankle shame KT ):
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06065488
Brief Title
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Official Title
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MTI University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 - 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer
Keywords
plantar foot ulcers, ankle kinesiotap, wound healing, chronic wounds, diabetic patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1.Group A (Ankle KT group):
Arm Type
Experimental
Arm Description
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)
Arm Title
2.Group B (Control group Ankle shame KT ):
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
ankle kinesio tap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum plantar peak pressures of ulcerated foot
Description
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
Time Frame
Baseline then after 8 weeks
Secondary Outcome Measure Information:
Title
Ankle dorsiflexion range of motion of ulcerated foot
Description
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.
Time Frame
Baseline then after 8 weeks
Title
Wound surface area by +Wound Desk mobile application
Description
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
Time Frame
Baseline then after 8 weeks
Title
Wound volume assessment
Description
- 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
Time Frame
Baseline then after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
El fahl, ph.d
Phone
00201097782441
Email
nn_ee_mm_oo@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
El feky, ph.d
Phone
00201014450994
Email
hebaelfeky61@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
El fahl, ph.d
Organizational Affiliation
faculty of physical therapy .Modern university for information and technology
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Mohamed Ahmed Abdelhady
City
Cairo
ZIP/Postal Code
11571
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El Fahl, ph.d
Phone
00201097782441
Email
nn_ee_mm_oo@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26342178
Citation
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.
Results Reference
background
PubMed Identifier
32176438
Citation
Lazzarini 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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=effectiveness+of+offloading+interventions+to+heal+foot+ulcer+in+persons+with+diabetes%3A+a+systematic+review
Description
Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review
Learn more about this trial
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
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