Plasma and Scarring of Diabetic Ulcers

NCT04145154 | Completed

• 1 other identifier: Plasma
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Skin Ulcer; Diabetic Foot; Plasma Protein; Transport Protein

Keywords

Platelet; Diabetic foot

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in the major and minor diameters of ulcers

  Up to four weeks

• Change in pain intensity

  Up to four weeks

Study Arms (2)

Plasma

EXPERIMENTAL

Subjects to whom platelet rich plasma is applied

Other: Application of platelet rich plasma in chronic wounds of diabetic origin

Advanced cure

NO INTERVENTION

Subjects to whom advanced healing is performed

Interventions

Application of platelet rich plasma in chronic wounds of diabetic origin OTHER

Application of plasma rich in autologous growht factors after advanced healing

Also known as: Advanced cure

Plasma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic ulcers of diabetic origin of more than 4 weeks of evolution in lower extremities with treatment with hypoglycemic and/or insulin.
• Age over 18 years and under 75 years, both genders.
• Platelet count greater than 100,000 platelets per mm3.
• Serum Hb level of \> 9 g/dl both genders and\<18 g/dl in men and \<16 g/dl in women.
• HbA1c level \<8%
• Serum triglyceride level \<300 mg/dl.
• Grade IA and IIA ulcers according to Texas classification.
• Dimension greater than 3 cm in any of its diameters. 9. Ankle-arm index \>0.7.

You may not qualify if:

• Chronic ulcers of traumatic, neoplastic, infectious, vascular and ischemic origin.
• Evidence of malignant ulcer
• Clinical evidence of ulcer infection at the start of treatment such as purulent secretion, local hyperthermia or active systemic infection.
• Haematological or coagulation disturbances.
• Carriers of syphilis, HIV, Hepatitis Virus B and C.
• Chronic use of corticosteroids

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37000, Mexico

Location

Related Publications (11)

• 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.

  PMID: 17580028 BACKGROUND

• 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.

  PMID: 27483482 BACKGROUND

• 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.

  PMID: 28241824 BACKGROUND

• 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.

  PMID: 25722604 BACKGROUND

• 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.

  PMID: 21200268 BACKGROUND

• 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.

  PMID: 27556760 BACKGROUND

• 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.

  PMID: 20489388 BACKGROUND

• 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.

  PMID: 27234711 BACKGROUND

• 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.

  PMID: 25934972 BACKGROUND

• Savelyeva EN, Kudryavtsev AM. [AFLP Analysis of Genetic Diversity in the Genus Mallus Mill. (Apple)]. Genetika. 2015 Oct;51(10):1126-33. Russian.

  PMID: 27169227 BACKGROUND

• 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.

  PMID: 27223580 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• GLORIA B SABANERO, DOCTOR

  Universidad de Guanajuato

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 30, 2019
• Study Start: June 5, 2018
• Primary Completion: April 30, 2020
• Study Completion: May 28, 2020
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)