Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004529788680 Date of Approval: 17/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title High versus low frequency transcutaneous electric nerve stimulation on venous lower limb ulceration
Official scientific title High versus low frequency transcutaneous electric nerve stimulation on wound surface area,wound volume and pain in patients with venous lower limb ulceration
Brief summary describing the background and objectives of the trial Chronic wounds such as diabetic foot ulcers, venous ulcers, and pressure ulcers are major sources of morbidity and mortality(Golinko et al., 2009). The cost of wound care is significant. The most important components are the costs of wound-related hospitalisation and the opportunity cost of nurse time. The 32% of patients treated in hospital accounted for 63% of total costs(Vowden et al., 2009). Electrical stimulation may offer a unique treatment option to heal complicated and recalcitrant wounds, improve flap and graft survival, and even improve surgery results. Electrical stimulation has been suggested to reduce infection, improve cellular immunity, increase perfusion, and accelerate wound healing(Thakral et al., 2013). Some authors have observed that TENS also promotes alterations in skin temperature, increases in local blood flow and the release of vasodilator neuropeptides and growth factors. These events may be related to the positive effects of TENS on wound healing and on the feasibility of skin flaps(Mechado et al.,2012). There are two main types of TENS namely high frequency and low frequency adjusted for healing of venous lower limb ulceration .but till now there is no judgment concerning the difference and significance of both so, the present study will be conducted to determine the effects of high versus low- frequency transcutaneous electric nerve stimulation on venous lower limb ulceration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2020
Actual trial start date 01/05/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group high frequency transcutaneous electric nerve stimulation 3 times a week 2 months This group included 20 patients with chronic unhealed lower limb ulcers for longer than three months, with different causes and they will receive high frequency TENS Frequency (80-120) HZ Intensity 15 MA Pulse duration 200 Micro sec (two channels will be used for application) with their medical treatment (Houghton, 2016). APPLICATION: 1st channel: Periwound area 1cm away from edge of wound (Machado et al ., 2016) 2nd channel: Mid - calf area on the medial side of the tibia (half way between the knee and ankle) (Kameli et al., 2017) For 60 minutes 20
Experimental Group low frequency transcutaneous electric nerve stimulation 3 times a week 2 months This group included 20 patients with chronic unhealed lower limb ulcers for longer than three months, with different causes and they will receive low frequency TENS Frequency (1-4) HZ Intensity 15 MA Pulse duration 200 Micro sec (two channels will be used for application) with their medical treatment (Houghton, 2016). APPLICATION: 1st channel: periwound area 1cm away from edge of wound (Machado et al., 2016) 2nd channel: Mid - calf area on the medial side of the tibia (half way between the knee and ankle) (Fahimeh et al., 2017) For 60 minutes, 3 sessions per week for 2 months (Thakral et al., 2013) 20
Control Group medical treatment 3 times a week 2 months This group included 20 patients with chronic unhealed lower limb ulcers for longer than three months , they will receive medical treatment only and dressing according their cases 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• The patients’ ages will be ranged from 45 to 60 years (Debreceni et al., 1995). • The patients will be chosen from both sexes. • Patient with chronic lower limb ulcers will be selected. • The duration of disease is longer than 3 months. • The patients who have skin malignancy in the area to be treated. • The patients who have severe anemia. • Patient with skin allergy. • Patient with cortisone therapy. • Severe uncontrolled hypertension. • Pregnant women. • Diabetic ulcer un controlled diabetes Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2020 faculty of physical therapy ethical commitee
Ethics Committee Address
Street address City Postal code Country
7th elzayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Computerized photographic wound surface area assessment equipment: - Canon EOS 4000d Digital Camera - ImageJ 1.47. computer software was used to measure wound surface area before,after one month and after two months
Primary Outcome Wound volume assessment tools Using sterilized siring saline , filling the wound with saline with known volume is a simple technique for wound volume assessment before,after one month and after two months
Secondary Outcome Pain assessment by :The visual analog scale (VAS) is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel (10) before,after one month and after two months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Imbaba general hospital 1 ibn Khaldoun Sq.,Imbaba Giza 12651 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed ElFahl 7th el-zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Modern University for Technology and Information. Hadaba El-Wosta mokattam cairo 11585 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Mohamed Abd El Baky 7th el-zayat street giza 12511 Egypt
Mohamed Taha Yousef Madkour 7th el-zayat street giza 12511 Egypt
Hany Mohamed Ibrahim El gohary 7th el-zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Fahl nn_ee_mm_oo@yahoo.com 01097782441 7th el zayat streat
City Postal code Country Position/Affiliation
giza 12511 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Amal Abd El Baky amalabaky@yahoo.com 01124663339 7th el zayat streat
City Postal code Country Position/Affiliation
giza 12511 Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Hany El gohary gohary75pt@hotmail.com 01093182291 7th el zayat streat
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trial 1-wound surface area 2-wound volume 3-pain Study Protocol one year the criteria will be accessed by the publication of trial in international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information