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.: PACTR202101805407126 Date of Approval: 12/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Hyperbaric Oxygen Therapy on Sensorimotor Functions in Diabetic Peripheral Neuropathy
Official scientific title Influence of Hyperbaric Oxygen Therapy on Sensorimotor Functions in Diabetic Peripheral Neuropathy
Brief summary describing the background and objectives of the trial Hyperbaric oxygen therapy (HBOT) involves breathing 100 % oxygen in a pressurized room or tube and is a well-established rst choice treatment for decompression sickness and gas poisoning. Although HBOT is widely used for the treatment of various clinical diseases, multiple studies indicated its benet in conditions of vascular pathology with conrmed effect on healing of chronic wounds, prevention of minor or major amputations especially in diabetic patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Hyperbaric Oxygen Therapy
Anticipated trial start date 06/01/2021
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group medical treatment The prescribed drugs included 1- anti diabetic drugs 2- B vitamins 3- Alpha lipoic acid (Thioctic acid) 600 mg 2 months The prescribed drugs included 1- anti diabetic drugs 2- B vitamins 3- Alpha lipoic acid (Thioctic acid) 600 mg 20 Active-Treatment of Control Group
Experimental Group Hyperbaric oxygen therapy started with a gradual increase of oxygen pressure to be approximately 2.5 ATA through 15 minutes in a 100% oxygen delivered for 60 minutes Then, gradual decompression through 15 minutes for a total of 90 minutes per each session for 30 sessions (5 sessions per week for 8 weeks). 2 months started with a gradual increase of oxygen pressure to be approximately 2.5 ATA through 15 minutes in a 100% oxygen delivered for 60 minutes Then, gradual decompression through 15 minutes for a total of 90 minutes per each session for 30 sessions (5 sessions per week for 8 weeks). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- patients with type 2 diabetes since < 10 years of both genders ( 2- both genders were included 3- with ages ranged from (40-65 years) 4- all patients had controlled blood glucose levels all over the whole duration of the study in which (HbA1C <48 mmol/mol). 5- All Patients had Cardiac Ejection Fraction (CEF) ≥ 50%, blood pressure (BP) ≤ 150/90 mmHg, Chest X-ray of all patients reported normal 6- all patients were clinically evaluated by a specialized ear, nose, and thorax (ENT) physician to ensure fitting for the hyperbaric chamber. Patients were excluded from the study if they had 1- chronic obstructive pulmonary disease 2- malignancy 3- cardiac pacemakers 4- any disorder that lead to pripheral neuropathy other than diabetes Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 64 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 17/09/2020 Ethical committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nerve conduction studies including latency, amplitude, and velocity. Pre-test and post-test
Secondary Outcome Michigan Neuropathy Screening Instrument Pre-test and post-test
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
foot care center at Kobri El Koba Military Complex Hospital Kobry El Qobba St. KOBRY EL KOBA. Heliopolis, Cairo Governorate Cairo 11711 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadee 51 Ebn Fadle El Omery. Toson street. Shoubra Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Ebn Fadle El Omery. Toson Street. Shoubra Cairo 11672 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Ebn Fadle El Omery Toson Street Shoubra Cairo 11672 Egypt
Seham Fahmy Kobry El Qobba St. KOBRY EL KOBA Heliopolis, Cairo Governorate Cairo 11711 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 01222367919 51 Ebn Fadle El Omery Toson Street Shoubra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor in Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Seham Fahmy fahmysiham@gmail.com 01272346919 Kobry El Qobba St. KOBRY EL KOBA Heliopolis, Cairo Governorate
City Postal code Country Position/Affiliation
Cairo 11711 Egypt PhD in Physical Therapy for Surgery and Head of HBO and Foot Care Center at Kobri El koba military hospital
Role Name Email Phone Street address
Scientific Enquiries Amir N Wadee anazih@cu.edu.eg 01222367919 51 Ebn Fadle El Omery Toson Street Shoubra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor in Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data will be shared Informed Consent Form,Statistical Analysis Plan 12 months international publication
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