NCT04145154|Completed
Plasma and Scarring of Diabetic Ulcers
Effect of the Rich Plasma in Growth Factors on the Cicatrization of Diabetic Ulcers
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Effect of the Rich Plasma in Growth Factors on the Cicatrization of Diabetic Ulcers
Sponsor study identifier
interventional
16
1 country
1
Study Start
June 5, 2018
Actual (reported)Primary Completion
April 30, 2020
Actual (reported)Study Completion
May 28, 2020
Actual (reported)Diabetic foot is defined by World Health Organization as a syndrome in which the presence of neuropathy, ischemia and infection cause tissue damage or ulcers from minor trauma. This condition can be controlled in its early stages with conservative treatment, which is effective in preventing infections and amputations. However, even with the new knowledge acquired and the development of new therapies, the specialist often faces wounds that do not improve despite the proper treatment, so therapies have been sought to help the healing of these Ulcers. Growing evidence suggests that healing of chronic diabetic foot ulcers depends on growth factors and that the therapeutic use of these in wounds has the potential to accelerate their healing in conjunction with wound care Conventional. This study evaluates the effect of plasma rich in autologous growth factors on healing chronic ulcers of diabetic origin. This is a randomized clinical trial that evaluates two study groups. Control group in which advanced weekly healing will be performed while the post-advanced healing study group will be performed the intradermal application of plasma rich in growth factors. These manoeuvres will be performed once a week for four weeks and at the end of the study the results in both groups will be checked. Both groups will also evaluate, frequency and intensity of pain, quality of life, histological changes in ulcers and metabolic evaluation
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 28, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2018
Actual (reported)October 22, 2019
Actual (reported)October 30, 2019
Actual (reported)April 30, 2020
Actual (reported)May 28, 2020
Actual (reported)Changing the dimensions of the ulcer area
The area of the ulcers will be measured every week in both groups in square centimeters recording the change
Up to four weeks
Change in the major and minor diameters of ulcers
Up to four weeks
Change in pain intensity
Up to four weeks
Subjects to whom platelet rich plasma is applied
Subjects to whom advanced healing is performed
Application of plasma rich in autologous growht factors after advanced healing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Guanajuato
León, Guanajuato, 37000, Mexico
Lazaro-Martinez JL, Garcia-Morales E, Beneit-Montesinos JV, Martinez-de-Jesus FR, Aragon-Sanchez FJ. [Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers]. Cir Esp. 2007 Jul;82(1):27-31. doi: 10.1016/s0009-739x(07)71657-3. Spanish.
Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
GLORIA B SABANERO, DOCTOR
Universidad de Guanajuato
16 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2019
First Posted
October 30, 2019
Study Start
June 5, 2018
Actual (reported)Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot
Contact the study team to confirm eligibility.
Suthar M, Gupta S, Bukhari S, Ponemone V. Treatment of chronic non-healing ulcers using autologous platelet rich plasma: a case series. J Biomed Sci. 2017 Feb 27;24(1):16. doi: 10.1186/s12929-017-0324-1.
Suresh DH, Suryanarayan S, Sarvajnamurthy S, Puvvadi S. Treatment of a non-healing diabetic foot ulcer with platelet-rich plasma. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):229-31. doi: 10.4103/0974-2077.150786.
Hahm G, Glaser JJ, Elster EA. Biomarkers to predict wound healing: the future of complex war wound management. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:21S-26S. doi: 10.1097/PRS.0b013e3181fbe291.
Lindley LE, Stojadinovic O, Pastar I, Tomic-Canic M. Biology and Biomarkers for Wound Healing. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):18S-28S. doi: 10.1097/PRS.0000000000002682.
Cervelli V, De Angelis B, Lucarini L, Spallone D, Balzani A, Palla L, Gentile P, Cerulli P. Tissue regeneration in loss of substance on the lower limbs through use of platelet-rich plasma, stem cells from adipose tissue, and hyaluronic acid. Adv Skin Wound Care. 2010 Jun;23(6):262-72. doi: 10.1097/01.ASW.0000363551.82058.36.
Singh B, Goldberg LJ. Autologous Platelet-Rich Plasma for the Treatment of Pattern Hair Loss. Am J Clin Dermatol. 2016 Aug;17(4):359-67. doi: 10.1007/s40257-016-0196-2.
Cobos R, Aizpuru F, Parraza N, Anitua E, Orive G. Effectiveness and efficiency of platelet rich plasma in the treatment of diabetic ulcers. Curr Pharm Biotechnol. 2015;16(7):630-4. doi: 10.2174/138920101607150427111926.
Savelyeva EN, Kudryavtsev AM. [AFLP Analysis of Genetic Diversity in the Genus Mallus Mill. (Apple)]. Genetika. 2015 Oct;51(10):1126-33. Russian.
Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, Exposito JA, Bolibar I, Rodriguez L, Garcia J, Zaror C. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2016 May 25;2016(5):CD006899. doi: 10.1002/14651858.CD006899.pub3.
Primary Completion
April 30, 2020
Actual (reported)Study Completion
May 28, 2020
Actual (reported)Last Updated
November 4, 2022
Record last verified: 2022-11
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