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Investigating the effect of oxygen therapy dressing for the treatment of diabetic foot ulcers containing granulation tissue

Protocol summary

Study aim
Determining the effect of a new oxygen-based wound treatment dressing in the healing of diabetic wounds containing granulation tissuef
Design
Phase 1 and 2 clinical trial without blinding and control group, 20 patients are randomly selected to be assigned to intervention group
Settings and conduct
Patients' wounds are photographed , and these images undergo assessment using the Tissue Analytics software.
Participants/Inclusion and exclusion criteria
•age 40 to 64 years old ; Suffering diabetic foot ulcer at least 4 weeks, or suffering amputation wound; The initial area of the wound should be measured at least 0.5 and at most 25 square centimeters in the first visit; Having a wound with Wegener grade 1 and 2; Sufficient blood supply to involved organ during the three months before start of ; the study, by the ankle brachial index 0.7 to 1.3.; The studied wound has no necrotic tissue and needs debridement for at least 14 days before. •Suffering from an uncontrolled major disease such as cardiovascular disease, kidney, liver, lung, lupus, sickle cell anemia, and patients undergoing palliative treatment; Patients with an active malignancy, or history of malignancy in the wound; Sensitivity to treatment components; Patients with history of taking immunosuppressive drugs for more than 2 weeks, such as corticosteroids more than 10 mg daily and cytotoxic chemotherapy drugs, or placing topical steroids on the wound for at least one month before entering the study, or during the study; HbA1C >12%
Intervention groups
using novel oxygen-based wound dressing technique in diabetic patients
Main outcome variables
Complete healing of diabetic wounds, Percentage reduction of diabetic ulcers, incidence of dressing Complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240502061627N1
Registration date: 2024-05-18, 1403/02/29
Registration timing: registered_while_recruiting

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Maedeh Aslani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5429 6997
Email address
dr.maedehaslani70@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2025-05-15, 1404/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oxygen therapy dressing for the treatment of diabetic foot ulcers containing granulation tissue
Public title
Investigating the effect of a new oxygen-based wound treatment dressing in the healing of diabetic foot ulcers containing granulation tissue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged men and women (40 to 64 years old) • Suffering from a diabetic foot ulcer for at least 4 weeks, or suffering from an amputation wound The initial area of the wound should be measured at least 0.5 and at most 25 square centimeters in the first visit Having a wound with Wegener grade 1 and 2 (Wegener grade is explained below) • Sufficient blood supply to the involved organ during the three months before the start of the study, which is determined by the ankle brachial index of 0.7 to 1.3 The studied wound has no necrotic tissue and needs debridement for at least 14 days before
Exclusion criteria:
Suffering from an uncontrolled major disease such as serious cardiovascular disease, kidney, liver, lung, lupus, anemia, tuberculosis and patients undergoing palliative treatment. Patients with an active malignancy, or a history of malignancy in the wound Sensitivity to treatment components Patients with a history of taking immunosuppressive drugs for more than 2 weeks, such as corticosteroids more than 10 mg daily and cytotoxic chemotherapy drugs, or placing topical steroids on the wound for at least one month before entering the study, or during the study. or predicting the need for such treatment in the course of the study HbA1C >12%
Age
From 40 years old to 64 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Siences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
471764136
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.197

Health conditions studied

1

Description of health condition studied
healing wound
ICD-10 code
E10.5
ICD-10 code description
Type 1 diabetes mellitus with circulatory complications

Primary outcomes

1

Description
Complete healing of diabetic wounds
Timepoint
every 48 hours for 12 weeks
Method of measurement
Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.

2

Description
Percentage reduction of diabetic ulcers
Timepoint
every 48 hours for 12 weeks
Method of measurement
Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.

3

Description
incidence of dressing Complications
Timepoint
every 48 hours for 12 weeks
Method of measurement
Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intervention group: using a novel oxygen-based wound dressing technique in diabetic patients with foot ulcers featuring granulation tissue. The intervention involves a thorough assessment process to ensure the safety and efficacy of a new oxygen-based wound treatment (TOT) for diabetic foot ulcers. The study is divided into two phases: first the safety of the new dressing is checked in 10 healthy volunteers in phase one. If there are no complications of the new dressing, in the second phase, the new dressing of oxygen-based wound treatment (TOT) along with standard wound treatment (SOC) will be investigated in 20 patients with diabetic foot ulcers. At the beginning of the study, patients are evaluated for previous documents, history, and examination to ensure that they meet the criteria for participating in the study. Then, the initial condition of the wound is checked in terms of the number, area, and observation of discharge or blood on the surface of the wound and evidence of infection. Standard wound treatment (SOC) includes cleaning the wound with water or sterile saline wash and, if needed, standard wound debridement, using TCC (Total Contact Casting) to remove weight from the injured leg and maintain wound moisture using hydro fiber dressing. All patients are advised to follow the study protocol and to go to the clinic immediately if symptoms of infection appear. TOT includes a wound oxygen therapy system that uses a small size oxygen storage dressing. This dressing stores about 3 milliliters of oxygen in itself, and after being placed on the wound, it should be well sealed around it with an impermeable adhesive so that oxygen gas does not escape from the wound. The oxygen delivery system is a sterile and disposable device that has a mesh design that allows oxygen to be delivered to the wound surface and allows wound exudate to be absorbed through secondary dressings and sterile gas. The oxygen delivery system is carried out through a Prussian media plate that is placed inside a small oxygen storage chamber. While the oxygenation dressing can be left in place for four days, it should be changed at each dressing change, based on the level of exudate or clinical judgment. This system has a lifespan of 4 days if it is fully sealed. Each participant is advised to inform the doctor at the next visit if the dressing is punctured or damaged, and its seal is compromised. Patients are followed up every 48 hours for 12 weeks. Patient follow-up includes the following:• Does the patient follow the study protocol?• Was the initial wound closed?• Is there any discharge or blood or evidence of infection on the surface of the wound?• If the wound is open, how many millimeters is its area?• Is there a new wound in the treated area? Patients' wounds are photographed at each follow-up stage, and these photographs are subjected to two-dimensional and three-dimensional evaluation with the latest version of Tissue Analytics software for Android. The examination of the patients is done by the relevant assistant and the photos are reviewed by the main executive of the plan. Patients are also evaluated for the occurrence of treatment complications. If a wound infection occurs, it is considered a complication and is treated in the standard way. These patients are not excluded from the study, unless the treatment measures interfere with the study protocol or meet the exclusion criteria. Patients are excluded from the study if they do not agree to continue the study, do not follow the protocol, or need to use another treatment regimen at any stage of the visit.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mahmood Sadeghi hadad zavareh
Street address
Ganjafrooz Avenue, Daneshgah Square, Ruhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 991 730 7280
Email
drm_sadeghihz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahmod Sadeghi hadad zavareh
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3231 2345
Email
drm_sadeghihz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahmood Sadeghi hadad zavareh
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3231 2345
Email
drm_sadeghihz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahmood Sadeghi hadad zavareh
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3231 2345
Email
drm_sadeghihz@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is still no plan for its publish
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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