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IRCT20230916059439N2 IRCT 2026-01-21 Aseman-e-Sharg Health Home Company The Efficacy of Topical Application of Honey Health Gel in Combination with Collagen on Diabetic Foot Ulcers The Efficacy of Topical Application of Honey Health Gel in Combination with Collagen on Diabetic Foot Ulcers in Patients Referring to Medical Centers 2026-01-21 anticipated 96 Complete https://irct.ir/trial/88534 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: the sampling method is based on the available method according to the criteria for entering the research . first , patients with type of diabetes that have the inclusion criteria in the study will be selected by available method and then randomly assigned to the three groups by using the three permutation blocks (ABC, CAB, BAC ) . the choice of blocks is done randomly using dice throwing to sufficient sample size ( 96 people ) . the samples that were selected by available sampling were selected according to the selected blocks in group A for the intervention of Honey Health Gel and B for the combination of Honey Health Gel with collagen and C for control , Blinding description: prior to the study , informed consent of the company to participate in the study and eventual inclusion in one of the study groups ( randomly ) will be obtained . according to the method of random allocation that was mentioned in the sampling method , the patient was placed in group a or b or c . moreover , the researcher has trained the information about the wound that is without any knowledge about the wound condition . 3 Diabetic foot wound infection. Intervention 1: Intervention group: n addition to the standard method, Honey Health gel combined with collagen will be applied every other day and once every turn for 28 days. The intervention involves placing a layer of Honey Health gel mixed with collagen on the wound after cleaning and washing the wound, which will then be covered with a layer of gauze. In other words, Honey Health gel and collagen powder are mixed at a ratio of 3:2 on a sterile surface, and the resulting mixture is applied evenly on the wound using sterile forceps, and finally covered with a layer of gauze. Producers: Pars Takrokh and Treatta pharmaceutical company. Intervention 2: Intervention group: In addition to the standard method, Honey Health gel alone will be applied every other day and once every turn for 28 days. The intervention involves placing a layer of Honey Health gel on the wound after cleaning and washing the wound, which will then be covered with a layer of gauze. Producer: Pars Takrokh pharmaceutical company. Intervention 3: Control group: In the control group, the routine hospital care method will be used, which includes wound washing with normal saline and dressing with moist gauze. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Reza Ghorbani Noughabi
Asiasi Road (Roadside), Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 969169996 +98 915 925 9581 rezaghorbani8678@gmail.com Gonabad University of Medical Sciences scientific Moosa Sajjadi
Gonabad University of Medical Sciences, near Asian Road, Gonabad
Gonabad Iran (Islamic Republic of) 969169996 +98 915 533 6294 Sajjadi1975@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness and consent to participate in the study and completion of the informed consent form Age between 18 and 60 years Absence of diseases such as leukemia and immunodeficiency Use of the same (identical) antibiotic among participants Diabetic foot wound infection of grade 2, confirmed by an infectious disease specialist and based on IDSA criteria Diabetes confirmed by an infectious disease specialist Wound size grade 3 according to the Bates–Jensen wound assessment tool Presence of only one diabetic foot ulcer 18 years 60 years Both Patient death Unwillingness to continue participation during the study Occurrence of any disorder or specific condition during the study that precludes the use of Honey Health gel dressing in combination with collagen, such as concurrent use of any dressing other than the intervention dressing specified in this study Necessity of using any pharmacological or non‑pharmacological intervention affecting diabetic foot wound infection Wound size grade 5 according to the Bates–Jensen wound assessment tool L08.9 Local infection of the skin and subcutaneous tissue, unspecified N/A N/A Placebo Intervention group: n addition to the standard method, Honey Health gel combined with collagen will be applied every other day and once every turn for 28 days. The intervention involves placing a layer of Honey Health gel mixed with collagen on the wound after cleaning and washing the wound, which will then be covered with a layer of gauze. In other words, Honey Health gel and collagen powder are mixed at a ratio of 3:2 on a sterile surface, and the resulting mixture is applied evenly on the wound using sterile forceps, and finally covered with a layer of gauze. Producers: Pars Takrokh and Treatta pharmaceutical company Intervention group: In addition to the standard method, Honey Health gel alone will be applied every other day and once every turn for 28 days. The intervention involves placing a layer of Honey Health gel on the wound after cleaning and washing the wound, which will then be covered with a layer of gauze. Producer: Pars Takrokh pharmaceutical company Control group: In the control group, the routine hospital care method will be used, which includes wound washing with normal saline and dressing with moist gauze. Diabetic foot wound infection. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: IDSA tool and Bates‑Jensen tool. Aseman-e-Sharg Health Home Company Approved 2025-12-29 Ethics Committee of Gonabad University of Medical Sciences Research and Technology Vice-Chancellor of Gonabad University of Medical Sciences,near Asian Road, Gonabad, Khorasan Razavi Gonabad Razavi Khorasan Iran (Islamic Republic of)