Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05671250
Collaborator
(none)
30
1
3
17.6
1.7

Study Details

Study Description

Brief Summary

We propose a randomized controlled study to assess the efficacy of:
  1. Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR)

  2. EPO/ISDN/UFH cryogel dressing (Trigel) As adjuncts to standard-of-care (SOC) in the treatment of chronic DFUs compared to SOC alone for patients attending the DFU outpatient clinic at the Gastroenterology Centre, Mansoura University.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: PRP gel and SOC-treatment
  • Combination Product: EPO/ISDN/UFH cryogel dressing
  • Procedure: Standard of Care
Phase 2

Detailed Description

The tested treatments were manufactured, tested and optimized in the research laboratories of Pharmacy School, Mansoura University under ethical approval of Pharmacy School ethics committee and Medical School IRB committee.

Our primary objective is to test the hypothesis that the proposed treatments can significantly improve the wound area regression rate assessed weekly (cm2/week) for 8 weeks as compared to SOC treatment alone.

Our secondary objectives are to assess the following: the time to complete wound closure, the rate of complete wound closure and the rate of partial wound closure of ≥ 50% and ≥ 75% at end-of-treatment visit (week 8). Wound closure is confirmed when the wound remains closed at two follow up visits. The occurrence of any adverse effects either locally or systemically will be surveilled in order to assess the safety profile of the test formulations.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Novel Bioactive Smart Dressings for Diabetic Foot Ulcers: a Randomized Controlled Trial Comparing Efficacy of PRP-loaded Lyophilized Gel vs. Erythropoietin/Isosorbide Dinitrate Cryogel Scaffold vs. Standard of Care
Actual Study Start Date :
Jul 15, 2021
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRP gel and SOC-treatment

platelet-lysate loaded lyophilized gel in addition to standard of care

Combination Product: PRP gel and SOC-treatment
Platelet-lysate loaded sustained release thermo-gelling formulation

Experimental: Trigel and SOC-treatment

Erythropoietin/isosorbide dinitrate loaded cryogel scaffold in addition to standard of care

Combination Product: EPO/ISDN/UFH cryogel dressing
Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold

Active Comparator: standard of care alone

sharp debridement, saline washing and saline dressing

Procedure: Standard of Care
Sharp debridement, saline washing and regular saline dressing

Outcome Measures

Primary Outcome Measures

  1. Wound area regression rate [8 weeks]

    wound area regression rate assessed weekly (cm2/week)

Secondary Outcome Measures

  1. rate of complete wound closure [8 weeks]

    rate of complete wound closure (100% closure)

  2. rate of partial wound closure of ≥ 75% [8 weeks]

    rate of partial wound closure of ≥ 75%

  3. rate of partial wound closure of ≥ 50% [8 weeks]

    rate of partial wound closure of ≥ 50%

Other Outcome Measures

  1. Adverse effects [8 weeks]

    rate of adverse effects related to any of the interventions used

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Male or female age of ≥ 18

  2. Type 2 Diabetes Mellitus diagnosed as per the American Diabetic Association at the time of recruitment

  3. Patients with glycated haemoglobin (HbA1C) ≤ 9% within 4 weeks prior to randomization

  4. Patients with ulcer that meets the following criteria

  5. Ulcers classified as Grade 1, stage A (1A) ulcers using University of Texas (UT) classification system (ulcers are superficial not involving tendon, capsule or tendon and are non-infected and non-ischemic)

  6. Ulcer duration of 4 weeks or longer and hard to heal despite standard of care treatment (chronic ulcers)

  7. Ulcer has undergone recent debridement (2 weeks prior to screening)

  8. Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining and is comprised of healthy vascularized tissue

  9. Wound area at start of treatment between 2 sq.cm. and 10 sq.cm.

  10. No surgical revascularization of the limb with the DFU was done in the previous two months.

  11. Limb criteria: At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of 0.9 - 1.3.

  12. Patients who agree to conform to the off-loading requirements

  13. Provide written informed consent prior to admission into the study

Exclusion Criteria:
  1. Type 1 Diabetes Mellitus

  2. Patients who have undergone, in the 2-week period prior to enrolment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments

  3. Have a glycosylated haemoglobin (HbA1c) > 9.0%

  4. Have a body mass index (BMI) > 40 Kg/m2

  5. Have a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease

  6. Anaemia (Haemoglobin < 9 g/dL) or white Blood Cells count > 11,000/μL or platelets count < 100,000/μL or > 400,000/μL or liver function tests > 3 times upper normal lab values or Creatinine > 3 mg/dL; any indication of malnourishment (Albumin < 3 g/dL); INR > 2 or any other clinically significant blood and urinalysis tests per the physician's discretion

  7. Patients with haemochromatosis or unstable hypertension

  8. Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except type 2 diabetes or during screening period

  9. Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision

  10. Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception, or females who test positive on a blood-based pregnancy test.

  11. Patients with a history of allergy to one of tested components

  12. Patients on glyceryl trinitrate or Sildenafil treatment

  13. Patients with a history of any clinical or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational agent or may confound the interpretation of study results or might render the patient at high risk for treatment complications

  14. Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toaa Ashraf Mansoura Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Study Director: Toaa Ashraf, Mansoura University
  • Study Director: Amira Motawea, Mansoura University
  • Study Director: Marwa S. El-Dahhan, Mansoura University
  • Study Director: Fady Azmy, Mansoura University
  • Principal Investigator: Galal M. Abdelghani, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Toaa Ashraf, Assistant Lecturer, Mansoura University
ClinicalTrials.gov Identifier:
NCT05671250
Other Study ID Numbers:
  • R.21.10.1492
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023