Clinical trial NCT06470087: High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs
Official title: A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Lead sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.

Detailed description: The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 18 years of age or older.
* Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
* At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area.
* The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
* The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
* The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
* Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

  * Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg
  * Ankle-Brachial Index (ABI) between 0.7 and 1.3
  * Peripheral Vascular Resistance (PVR): Biphasic
  * Toe-Brachial Index (TBI) ˃0.6
  * As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
* If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
* The subject must consent to using the prescribed off-loading method for the duration of the study.
* The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
* The subject must be willing and able to participate in the informed consent process.
* Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.

Exclusion Criteria:

* A subject known to have a life expectancy of \<6 months.
* If the target ulcer is infected or if there is cellulitis in the surrounding skin.
* Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
* A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
* A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
* Topical application of steroids to the ulcer surface within one month of initial screening.
* A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
* A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
* A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.

  o A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
* Women who are pregnant or considering becoming pregnant within the next 6 months.
* A subject with end stage renal disease requiring dialysis.
* A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
* A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
* A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.

Primary outcomes:
measure: Change in Wound Area From Week 1 Through 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period
timeFrame: 4 weeks
measure: Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure
timeFrame: 4 Weeks
Other outcomes:
measure: Appearance
timeFrame: The appearance of thewound was assessed only once i.e at the end of 5th week.
measure: Structural Stability of the Scar
timeFrame: The appearance of the woundd was assessed only once i.e. at the end of 5th week.
measure: Wound Recurrence
timeFrame: During 1-week follow-up
Locations:
city: Mandya
country: India
facility: Adichunchanagiri Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: RajaRajeswari Medical College and Hospital
name: Prema Dhanraj, MS, MCh
role: STUDY_CHAIR
References:
citation: Dhanraj P, Naveen N, Babu KR, Mahesh MS, Hanumanthaiah KS. Healicoll: An alternate to flap cover for bare bones and tendons. Acta Medica International. 2016 Jan 1;3(1):146-50
citation: Wolfe EM, Mathis SA, de la Olivo Munoz N, Ovadia SA, Panthaki ZJ. Comparison of human amniotic membrane and collagen nerve wraps around sciatic nerve reverse autografts in a rat model. Biomater Biosyst. 2022 Apr 7;6:100048. doi: 10.1016/j.bbiosy.2022.100048. eCollection 2022 Jun.
citation: Mohammed YA, Farouk HK, Gbreel MI, Ali AM, Salah AA, Nourelden AZ, Gawad MMA. Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis. J Foot Ankle Res. 2022 Sep 14;15(1):71. doi: 10.1186/s13047-022-00575-y.
citation: DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Jacobs AM, Zelen CM. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018 Dec;15(6):950-957. doi: 10.1111/iwj.12954. Epub 2018 Jul 17.
citation: Huang Y, Kyriakides TR. The role of extracellular matrix in the pathophysiology of diabetic wounds. Matrix Biol Plus. 2020 Apr 22;6-7:100037. doi: 10.1016/j.mbplus.2020.100037. eCollection 2020 May.
citation: Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.