Platelet Rich Plasma and Diabetic Foot Ulcer

NCT04750837 | Completed Phase 2

• 1 other identifier: Platelet rich plasma
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.

Conditions

Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• size of the ulcer reduce to zero cm

  complete coverage of the ulcer base by healthy tissue

  20 weeks

Study Arms (2)

Platelet rich plasma group

ACTIVE COMPARATOR

chronic diabetic foot ulcer was treated by platelet rich plasma

Procedure: debridement of the wound; Biological: platelet rich plasma; Procedure: conventional dressing

conventional dressing group

SHAM COMPARATOR

chronic diabetic foot ulcer was treated by conventional dressing

Procedure: debridement of the wound; Procedure: conventional dressing

Interventions

debridement of the wound PROCEDURE

The edges and the floor of the wound were firstly debrided, and any callosities around the wound were removed. This was repeated if needed when callosities around the wound reappeared. By this technique, the chronic wound was transformed into an acute one

Platelet rich plasma group; conventional dressing group

platelet rich plasma BIOLOGICAL

Part of activated PRP was injected around the wound and under the base of the wound, while another portion of PRP was left over the floor of the wound and let to coagulate and form a gel.

Platelet rich plasma group

conventional dressing PROCEDURE

The wound was irrigated by normal saline, covered by vaseline gauze then sterile dressing. Repeated dressing every two days till 20 weeks, if the wound failed to heal at that time

Platelet rich plasma group; conventional dressing group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with chronic diabetic foot ulcers more than 1 cm in diameter that failed to heal in three months after wound debridement and dressing by a surgeon.

You may not qualify if:

• Patients with evident local infection or gangrene (no redness, no hotness, no purulent discharge, no osteomyelitis in X-ray with a negative probe to bone test, and negative C-reactive protein).
• Patients with end-stage organ failure, hepatic, or renal failure.
• Patients on anticoagulants.
• Patients on antiplatelet agents.
• Patients with thrombocytopenia.
• Patients on steroid therapy.
• Ulcers less than 1cm or greater than 8 cm in diameter.
• Deep ulcers more than 2 cm in depth.
• Patients with lower limb ischemia (acute or chronic). Limb ischemia was excluded by the detection of the distal limb pulsations with ankle-brachial index\>0.9.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Human Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (7)

• GREELEY PW. Plastic surgical closure of chronic open wounds of the leg. Ind Med Surg. 1953 Jan;22(1):22-3. No abstract available.

  PMID: 13022118 BACKGROUND

• CARLESON R, GARSTEN P. [Wound therapy with septofyllin, with special consideration of its effect on chronic leg ulcers]. Nord Med. 1952 Mar 28;47(13):412-6. No abstract available. Undetermined Language.

  PMID: 14941406 BACKGROUND

• Martin P, Nunan R. Cellular and molecular mechanisms of repair in acute and chronic wound healing. Br J Dermatol. 2015 Aug;173(2):370-8. doi: 10.1111/bjd.13954. Epub 2015 Jul 14.

  PMID: 26175283 BACKGROUND

• Leaper DJ, Durani P. Topical antimicrobial therapy of chronic wounds healing by secondary intention using iodine products. Int Wound J. 2008 Jun;5(2):361-8. doi: 10.1111/j.1742-481X.2007.00406.x.

  PMID: 18494641 BACKGROUND

• Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.

  PMID: 25486905 BACKGROUND

• Baba M, Davis WA, Norman PE, Davis TM. Temporal changes in the prevalence and associates of foot ulceration in type 2 diabetes: the Fremantle Diabetes Study. J Diabetes Complications. 2015 Apr;29(3):356-61. doi: 10.1016/j.jdiacomp.2015.01.008. Epub 2015 Jan 19.

  PMID: 25670409 BACKGROUND

• Jarbrink K, Ni G, Sonnergren H, Schmidtchen A, Pang C, Bajpai R, Car J. Prevalence and incidence of chronic wounds and related complications: a protocol for a systematic review. Syst Rev. 2016 Sep 8;5(1):152. doi: 10.1186/s13643-016-0329-y.

  PMID: 27609108 BACKGROUND

Study Officials

• Yasser A. Orban, Lecturer

  zagazig university faculty of human medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 2 groups one group managed by conventional dressing and the other by platelet rich plasma

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 11, 2021
• Study Start: January 16, 2020
• Primary Completion: December 21, 2020
• Study Completion: January 20, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)