Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

NCT05671250 | Completed Phase 2

• 1 other identifier: R.21.10.1492
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a randomized controlled study to assess the efficacy of:

1. 1.Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR)
2. 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound area regression rate

  wound area regression rate assessed weekly (cm2/week)

  8 weeks

Secondary Outcomes (3)

• rate of complete wound closure

  8 weeks

• rate of partial wound closure of ≥ 75%

  8 weeks

• rate of partial wound closure of ≥ 50%

  8 weeks

Other Outcomes (1)

• Adverse effects

  8 weeks

Study Arms (3)

PRP gel and SOC-treatment

EXPERIMENTAL

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

Combination Product: PRP gel and SOC-treatment

Trigel and SOC-treatment

EXPERIMENTAL

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

Combination Product: EPO/ISDN/UFH cryogel dressing

standard of care alone

ACTIVE COMPARATOR

sharp debridement, saline washing and saline dressing

Procedure: Standard of Care

Interventions

PRP gel and SOC-treatment COMBINATION_PRODUCT

Platelet-lysate loaded sustained release thermo-gelling formulation

PRP gel and SOC-treatment

EPO/ISDN/UFH cryogel dressing COMBINATION_PRODUCT

Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold

Trigel and SOC-treatment

Standard of Care PROCEDURE

Sharp debridement, saline washing and regular saline dressing

standard of care alone

Eligibility Criteria

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

You may qualify if:

• Male or female age of ≥ 18
• Type 2 Diabetes Mellitus diagnosed as per the American Diabetic Association at the time of recruitment
• Patients with glycated haemoglobin (HbA1C) ≤ 9% within 4 weeks prior to randomization
• Patients with ulcer that meets the following criteria
• 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)
• Ulcer duration of 4 weeks or longer and hard to heal despite standard of care treatment (chronic ulcers)
• Ulcer has undergone recent debridement (2 weeks prior to screening)
• Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining and is comprised of healthy vascularized tissue
• Wound area at start of treatment between 2 sq.cm. and 10 sq.cm.
• No surgical revascularization of the limb with the DFU was done in the previous two months.
• Limb criteria: At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of 0.9 - 1.3.
• Patients who agree to conform to the off-loading requirements
• Provide written informed consent prior to admission into the study

You may not qualify if:

• Type 1 Diabetes Mellitus
• 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
• Have a glycosylated haemoglobin (HbA1c) \> 9.0%
• Have a body mass index (BMI) \> 40 Kg/m2
• Have a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease
• 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
• Patients with haemochromatosis or unstable hypertension
• 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
• Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision
• 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.
• Patients with a history of allergy to one of tested components
• Patients on glyceryl trinitrate or Sildenafil treatment
• 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
• Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Toaa Ashraf

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Toaa Ashraf

  Mansoura University

  STUDY DIRECTOR

• Amira Motawea

  Mansoura University

  STUDY DIRECTOR

• Marwa S. El-Dahhan

  Mansoura University

  STUDY DIRECTOR

• Fady Azmy

  Mansoura University

  STUDY DIRECTOR

• Galal M. Abdelghani

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 4, 2023
• Study Start: July 15, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)