Volume 18, Issue 3 (3-2019)
ijdld 2019, 18(3): 126-134 |
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Alamouti M A, Shayan N, Momeni M, Nouri M, Koohkan A, Hajizadeh-Saffar E, et al . INVESTIGATION ON THE SAFETY OF AMNIOTIC MEMBRANE EXTRACTS IN IMPROVING DIABETIC FOOT ULCERS (PHASE 1 CLINICAL TRIAL STUDY). ijdld 2019; 18 (3) :126-134
URL: http://ijdld.tums.ac.ir/article-1-5793-en.html
URL: http://ijdld.tums.ac.ir/article-1-5793-en.html
Mohammad Azimi Alamouti1 
, Niloufar Shayan2 , Maryam Momeni2 , Masoumeh Nouri2 , Azam Koohkan2 , Ensiyeh Hajizadeh-Saffar2 , Fatemeh Soltanolizadeh2 , Maliheh Mahmoudi2 , Mahin Jamshidi Makiani * 3, Marzieh Ebrahimi2
, Niloufar Shayan2 , Maryam Momeni2 , Masoumeh Nouri2 , Azam Koohkan2 , Ensiyeh Hajizadeh-Saffar2 , Fatemeh Soltanolizadeh2 , Maliheh Mahmoudi2 , Mahin Jamshidi Makiani * 3, Marzieh Ebrahimi2
1- Department of Tissue Engineering, School of Advanced Technologies in Medicine, Royan Institute, Tehran, Iran
2- Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
3- Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences,Tehran Iran
2- Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
3- Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences,Tehran Iran
Abstract: (4433 Views)
Background: For nearly 100 years, amniotic membranes have been used to treat various types of skin wounds. Amniotic extract is one of the derivatives of amniotic membrane that contains all the properties of amniotic membrane. The aim of this study was to evaluate the safety of the amniotic membrane extract in the treatment of diabetic ulcers.
Methods: This study was an Open labeled clinical trial without control group. A total of 10 patients with Wagner Grade 2 diabetic foot ulcers were selected in both sexes. The extract was used every 48 hours in the first week and every 72 hours from the second week until the end of the wound treatment. Patients were followed up weekly until wound healing.
Results: In this study 80% of patients were men and 20% were women with mean age (56.7 ± 8.7) years. The ulcer duration was 8.9 ± 2.12 weeks. The mean area of ulcers at the time of entry into the wound group ≥ 500 mm2, 977.5 ± 201.9 and in the wound group ≤500 mm2 was 145.6 ± 36.4. At 4 weeks post treatment, the wound healing rate in the wound group was ≤500mm2 ,98.9 ± 2.40 % and in the wound group ≥mm2 500 was 92.1 ± 7.23%. in sixth week of treatment, ulcers were complete closure in both groups.
Conclusion: The results of this study suggest that the use of amniotic extract can be effective in the healing of diabetes foot ulcer without any side effects.
Methods: This study was an Open labeled clinical trial without control group. A total of 10 patients with Wagner Grade 2 diabetic foot ulcers were selected in both sexes. The extract was used every 48 hours in the first week and every 72 hours from the second week until the end of the wound treatment. Patients were followed up weekly until wound healing.
Results: In this study 80% of patients were men and 20% were women with mean age (56.7 ± 8.7) years. The ulcer duration was 8.9 ± 2.12 weeks. The mean area of ulcers at the time of entry into the wound group ≥ 500 mm2, 977.5 ± 201.9 and in the wound group ≤500 mm2 was 145.6 ± 36.4. At 4 weeks post treatment, the wound healing rate in the wound group was ≤500mm2 ,98.9 ± 2.40 % and in the wound group ≥mm2 500 was 92.1 ± 7.23%. in sixth week of treatment, ulcers were complete closure in both groups.
Conclusion: The results of this study suggest that the use of amniotic extract can be effective in the healing of diabetes foot ulcer without any side effects.
Keywords: Diabetes Mellitus, Diabetic Foot Ulcer, Amniotic Membrane Extract, Amniotic Membrane, Wound Healing
Type of Study: Research |
Subject:
General
Received: 2018/10/11 | Accepted: 2019/03/11 | Published: 2019/03/15
Received: 2018/10/11 | Accepted: 2019/03/11 | Published: 2019/03/15
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