NCT04145154

Plasma and Scarring of Diabetic Ulcers

Completed NA Last updated 4 November 2022

What this trial tests

NA trial testing Application of platelet rich plasma in chronic wounds of diabetic origin in Chronic Skin Ulcer in 16 participants. Completed in 28 May 2020.

Timeline

5 June 2018

Primary endpoint
30 April 2020

28 May 2020

Quick facts

Lead sponsor	Universidad de Guanajuato
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	16
Start date	5 June 2018
Primary completion	30 April 2020
Estimated completion	28 May 2020
Sites	1 location across Mexico

Drugs / interventions tested

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

Conditions studied

• Chronic Skin Ulcer — all drugs for Chronic Skin Ulcer →
• Diabetic Foot — all drugs for Diabetic Foot →
• Plasma Protein; Transport Protein — all drugs for Plasma Protein; Transport Protein →

Sponsor

Universidad de Guanajuato — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Skin Ulcer or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.