Evaluation of Dermaheal Ointment Healing Effects on Diabetic Foot Ulcer: Double-Blind Randomized Clinical Trial Study

Evaluation of Dermaheal Ointment Effects on Foot Ulcers in diabetic patients

In this study, diabetic patients either type 1 or type 2 with a nonhealing wound at the Clinic of Diabetes Research Center, Endocrinology and Metabolism Research, Tehran University of Medical Sciences. Patients are then randomly divided into two groups A and B (Dermahil or Eucerine) using a randomized randomized table. In both groups wound and surrounding tissues will be irrigated by normal sterile saline and then dried with sterile gauze. Wounds will be treated by Placebo or Dermaheal Ointment under A or B Ointments. Ointments should be used for 4 consecutive weeks once a day with changing the dressing. At the end of each week, based on checklists and digital images, the effectiveness of the dermaheal in the treatment of diabetic ulcers will be assessed.

Diabetes Clinic - DRC

Study inclusion criteria : 1- Wegener G 1 and 2 diabetic ulcers 2 - 4 weeks old wound in the area of legs and extremities (toes, soles of the feet, heels, on the toes) 3 - Age: 18 to 80 years 4 - Body mass index: 35 -18 5 - Wound area: 1 to 30 square centimeters 6 - 0.7 ≤ ABI ≤ 1.2 7 - Being consciousness at the beginning of the study Inclusion criteria: 1 - Smoking and drug addiction 2- Taking medications that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents 3 - Simultaneous disease that may have negatively affect wounds healing such as cancer, vasculitis, kidney and liver failure, advanced heart failure

Placebo group (standard treatment with Eucerin) and treatment group (standard treatment with Dermaheal ointment)

Area of ulcer Wound color Wound discharge

The first step in the random process is to create a random sequence. The second step after creating a random sequence is to hide the generated sequence. To use the random number table, we must first determine the number of the table to read. The second is to consider numbers for different groups (for example, pair numbers for intervention A and individual numbers for intervention B, then hand over one of the numbers and move in one of the directions predetermined and record the numbers We assign to different groups. Blocking is usually used to create a balance in the number of specimens assigned to each of the groups studied, for example, in blocks of 4 that have two allocations to the intervention group and two allocations to the control group Is taken.

Given the fact that the treatments are prescribed as unprinted tubes, also the appearance of both ointments is similar in both control and intervention groups, the patient will not be informed about her/his assignment to the control or intervention group. Forasmuch as groups will be marked by letters A and B; and patient assignment to either A or B groups will be done using block randomization, therefore, the treating and wound assessor physician will not be informed of the patient's group assignment when examining the wound using a checklist. This will reduce the observation bias (data collection) which arises from mental presupposition. The second principal researcher will also be unaware of the grouping details. Finally, the statistician will statistically analyze the data without knowing the treatment assigned to group A or B. The First Principal researcher is not blinded and can reopen the codes and be informed about the received treatments of each patient (if necessary or and at the end of the study).

ethical

Wound healing checklist, Images, ABI

Per 3 month

Dr. Mohammad Reza Amini

Primary Evaluation of the Process and Under Certain Circumstances

Ethics Committee endocrine & Metabolism Research institute - Tehran University of Medical Sciences

Hand over to the Project Executor and he will refer to the Committee of Ethics